Age Related Macular Degeneration (AMD)MACUSTARNCT03349801
Development of Novel Clinical Endpoints in Intermediate AMD
An observational study of Age Related Macular Degeneration (AMD), run by Frank G. Holz at 20 sites in 7 countries.
Trial summary
Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration (AMD)
- How many people
- 718 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 26 Mar 2018to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include subjects with no AMD or normal aging changes and subjects with AMD classified in accordance with the international Beckman Classification. A total of 750 subjects will be recruited: * 300 subjects will participate in the Cross-sectional part: * 50 with normal aging changes, no AMD * 50 with early AMD, * 50 with late AMD * 150 with iAMD * 650 subjects will participate in the longitudinal part: * 600 iAMD * 50 early AMD
Who may be able to join
- General Inclusion criteria (applicable to all groups)
- Male and female subjects.
- Aged 55 - 85 years at baseline.
- Able and willing to provide written informed consent and to comply with the study protocol visits and assessments.
- Intermediate AMD
- Study eye must have iAMD and,
Show all 19Show fewer
- The fellow eye must have iAMD and/or, in addition, extrafoveal GA (no atrophy within the central ETDRS subfield), maximum total GA size is 1.25 mm2.
- ETDRS letter chart BCVA in the study eye not worse than 72 letters (approximately 20/40 Snellen VA equivalent).
- All general inclusion criteria.
- Late AMD
- Subjects with bilateral GA, bilateral nAMD or nAMD in one eye and GA in the other.
- BCVA between 20/80 and 20/200 in study eye.
- All general inclusion criteria.
- Early AMD
- Subjects with medium drusen > 63μm and ≤ 125μm and no AMD pigmentary abnormalities in both eyes and not signs of intermediate or late AMD.
- All general inclusion criteria.
- No AMD
- No signs of early, intermediate or late AMD in both eyes.
- All general inclusion criteria only.
Who cannot join
- General Exclusion criteria (applicable to all groups)
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator.
- Severe ptosis, extraocular motility restriction or head tremor preventing adequate fundus visualization in the opinion of the investigator.
- Any signs of nAMD or GA (does not apply to the late AMD group).
- Any concurrent intraocular condition in the study eye (e. g. glaucoma or cataract) that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
- Severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
Show all 27Show fewer
- Any diabetic macular edema or macular disease
- Ocular disorders in the study eye (i. e., pre-retinal membrane) at the time of enrolment that may confound interpretation of study results and compromise visual acuity.
- Diagnosis of uncontrolled glaucoma with intraocular pressure of >30 mmHg (despite current pharmacological or non-pharmacological treatment).
- Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study.
- Concomitant treatment for AMD in either eye (concomitant use of vitamins/supplements is not excluded; does not apply to the late AMD group).
- Any periocular or intravitreal injections (IVT) in either eye (does not apply to the late AMD group).
- Participation in any other interventional trial.
- Obvious retinal changes due to causes other than AMD (e.g. evidenced by an existing diagnosis of monogenetic macular dystrophies, Stargardt disease, cone rod dystrophy, or toxic maculopathies).
- Any history of allergies to fluorescein.
- Intermediate AMD
- Any GA in the study eye
- Any extrafoveal GA larger than 1.25 mm2 in the fellow eye.
- All general exclusion criteria.
- Late AMD
- 1. All general exclusion criteria only.
- Early AMD
- Intermediate or late AMD (following Beckman classification) in any eye.
- All general exclusion criteria.
- No AMD
- Early to late AMD (following Beckman classification) in any eye.
- All general exclusion criteria.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Germany7 sites
University Hospital Bonn
Bonn
University Hospital Cologne
Cologne
Department of Ophthalmology, University of Freiburg
Freiburg im Breisgau
University Eye Hospital Munich
Munich
St. Franziskus Hospital
Münster
Universtiy Hospital Tuebingen
Tübingen
University Eye Hospital Ulm
Ulm
Italy3 sites
Luigi Sacco Hospital
Milan
Ospedale San Raffaele
Milan
G.B.Bietti Eye Foundation
Rome
United Kingdom3 sites
Queen's University Belfast
Belfast
Gloucestershire Hospitals NHS Foundation Trust
Gloucester
Moorfields Eye Hospital
London
France2 sites
Centre Hospitalier Intercommunal de Creteil
Créteil
Centre d'Investigation Clinique Centre National d'Ophtalmologie des Quinze-Vingts
Paris
Netherlands2 sites
Radboud University Medical Centre
Leiden
Radboud University Medical Centre
Nijmegen
Portugal2 sites
Centre for Clinical Trials, AIBILI
Coimbra
Centro Hospitalar de São João, E.P.E.
Porto
About this study
Official title: Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)
Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR
Read the detailed description
The purpose of the MACUSTAR clinical study is to develop novel clinical endpoints for clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (iAMD). Additional objectives are to characterize the visual impairment in iAMD and its progression, as well as identify risk factors for progression to late stage AMD.
Moreover, MACUSTAR aims to optimize and standardize most relevant existing and/or rapidly available clinical endpoints in:
- visual functional outcomes measures
- structural outcomes measures
- patient reported outcomes measures (PROMs)
The study will be composed by two parts:
- a cross-sectional part to technically evaluate the functional and structural outcome measures to support a biomarker qualification by regulatory authorities and payers; and
- a longitudinal part to assess the prognostic power of changes in retinal sensitivity (as measured by microperimetry) for progression from iAMD to late AMD (nAMD and GA).
- Conditions
- Age Related Macular Degeneration (AMD)
- Being tested
- No intervention
- Keywords
- iAMD, biomarker, clinical endpoint
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
According to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| no AMD | No interventions Receives: Other: No intervention | |
| early AMD | No interventions. Receives: Other: No intervention | |
| intermediate AMD | No interventions. Receives: Other: No intervention | |
| late AMD | No interventions. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart
standard parameter, tested for comparison (reference variable)
Measured: 3 years from baseline
Mean change from baseline in scotopic and mesopic microperimetry sensitivity
Measured: 3 years from baseline
Mean change from baseline in low luminance visual acuity (LLVA)
Measured: 3 years from baseline
Mean change from baseline in vanishing optotypes visual acuity (VA)
Measured: 3 years from baseline
Mean change from baseline in low luminance deficit (LLD)
LLD = BCVA-LLVA
Measured: 3 years from baseline
Mean change from baseline in absolute rod threshold of the dark adaptation test
Measured: 3 years from baseline
Mean change from baseline in rod intercept time of the dark adaptation test
Measured: 3 years from baseline
Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural
Measured: 3 years from baseline
Mean change from baseline in the cube root of drusen volume by spectral-domain optical coherence tomography (SD-OCT)
Measured: 3 years from baseline
Mean change from baseline in retinal thickness by spectral-domain optical coherence tomography (SD-OCT)
Measured: 3 years from baseline
Focal pigmentary changes captured by colour fundus photography (CFP)
Measured: 3 years from baseline
Presence of refractile deposits
Measured: 3 years from baseline
Presence of intraretinal cystoid spaces
Measured: 3 years from baseline
Presence of localized retinal pigment epithelium (RPE) hypertransmission
Measured: 3 years from baseline
Presence of localized disruption of ellipsoid zone
Measured: 3 years from baseline
Presence of localized subsidence of the outer plexiform layer and the inner nuclear layer
Measured: 3 years from baseline
Presence of hyporeflective wedge-shaped bands
Measured: 3 years from baseline
Presence of reticular drusen/subretinal drusenoid deposits and associated local changes as determined by multimodal imaging
Measured: 3 years from baseline
Changes in localized fundus autofluorescence signal alterations
Measured: 3 years from baseline
Proportion of subjects with reduction in drusen volume
Measured: 3 years from baseline
Proportion of subjects with study eye that progressed to geogrphic atrophy (GA) and/or neovascular age-related macular degeneration (nAMD)
Measured: 3 years from baseline
Proportion of subjects with conversions to late AMD detected with fluorescein angiography (FA) that could be detected with OCT-A (at equipped sites)
Measured: 3 years from baseline
Presence of quiescent choroidal neovascularisation (CNV) as assessed by optical coherence tomography angiography (OCT-A) (at equipped sites)
Measured: 3 years from baseline
OCT-A findings (at equipped sites)
Measured: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the vision impairment in low luminance (VILL) questionnaire, including the domains of reading & accessing information
Measured: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of Orientation & mobility (incl. driving)
Measured: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of safety
Measured: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of socio-emotional well-being
Measured: 3 years from baseline
Change in utility index from baseline as measure by the patient-reported outcome measure (PROM) utility index
Measured: 3 years from baseline
Mean change from baseline in patient-reported health status and utility using the EQ-5D-5L questionnaire (EuroQol Group)
Measured: 3 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start26 Mar 2018
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank G. Holz
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Moorfields Eye Hospital NHS Foundation Trust, Novartis Pharmaceuticals, Association for Innovation and Biomedical Research on Light and Image, City, University of London, European Clinical Research Infrastructure Network, La Fondation Voir et Entendre, Hoffmann-La Roche, Radboud University Medical Center, University of Sheffield, University College, London, Carl Zeiss Meditec AG, Innovative Medicines Initiative
- Responsible party
- Sponsor-investigator, Frank G. Holz, University Hospital, Bonn
- Investigators
- Frank Holz, Prof. Dr. med., Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349801
- Sponsor's protocol ID
- ECR-AMD-2017-13
- Other IDs
- MACUSTAR
- Acronym
- MACUSTAR
- Status last verified
- Jan 2025
- First submitted
- 10 Nov 2017
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goerdt L, Bessaheken D, Terheyden JH, Thiele S, Basten V, Behning C, Luhmann U, Leal S, Moll KP, Zakaria N, Schmid M, Finger RP, Holz FG, Schmitz-Valckenberg S, Sassmannshausen M; MACUSTAR Consortium. Longitudinal analysis of structural biomarkers for disease progression in intermediate age-related macular degeneration: a MACUSTAR study report. Ophthalmol Retina. 2026 Oct 23:S2468-6530(26)00539-7. doi: 10.1016/j.oret.2026.10.005. Online ahead of print.
PubMed 42918418Vidal-Oliver L, Terheyden J, Behning C, Basten V, Kornau M, Schlosser L, Luhmann UFO, Moll KP, Zakaria N, Leal S, Schmid M, Valckenberg SS, Holz F, Finger RP, Sassmannshausen M; MACUSTAR consortium. Cuticular Drusen and the Risk of Progression to Late Age-Related Macular Degeneration: A MACUSTAR Study Report. Ophthalmol Sci. 2026 Aug 18;6(10):101375. doi: 10.1016/j.xops.2026.101375. eCollection 2026 Oct.
PubMed 42824051Rowen D, Carlton J, McDool E, Holz FG, Zakaria N, Terheyden JH, Finger RP; MACUSTAR Consortium. Psychometric Performance of a New Condition-Specific Preference-Weighted Measure, Vision Impairment in Low Luminance-Utility Index, and EQ-5D-5L in Patients With Age-Related Macular Degeneration: A MACUSTAR Study Report. Value Health. 2025 Jul;28(7):1082-1090. doi: 10.1016/j.jval.2025.04.2155. Epub 2025 Apr 26.
PubMed 40294859Terheyden JH, Dunbar HMP, Schmitz-Valckenberg S, Behning C, Martinho C, Luhmann UFO, Sassmannshausen M, Luning A, Miliu A, Aires ID, Basile PG, Batuca J, Schmid M, Moll KP, Zakaria N, Tufail A, Binns A, Crabb DP, Leal S, Finger RP, Holz FG; MACUSTAR consortium. Validating candidate endpoints for intermediate age-related macular degeneration trials in a multi-centre setting-lessons from the MACUSTAR study. Eye (Lond). 2025 Apr;39(6):1031-1039. doi: 10.1038/s41433-024-03568-2. Epub 2025 Feb 5.
PubMed 39910281Rowen D, Carlton J, Terheyden JH, Finger RP, Wickramasekera N, Brazier J; MACUSTAR Consortium. Development and Valuation of a Preference-Weighted Measure in Age-Related Macular Degeneration From the Vision Impairment in Low Luminance Questionnaire: A MACUSTAR Report. Value Health. 2024 May;27(5):642-654. doi: 10.1016/j.jval.2024.02.001. Epub 2024 Feb 17.
PubMed 38369283Sassmannshausen M, Behning C, Weinz J, Goerdt L, Terheyden JH, Chang P, Schmid M, Poor SH, Zakaria N, Finger RP, Holz FG, Pfau M, Schmitz-Valckenberg S, Thiele S; MACUSTAR Consortium Members. Characteristics and Spatial Distribution of Structural Features in Age-Related Macular Degeneration: A MACUSTAR Study Report. Ophthalmol Retina. 2023 May;7(5):420-430. doi: 10.1016/j.oret.2022.12.007. Epub 2022 Dec 20.
PubMed 36563964Garzone D, Terheyden JH, Morelle O, Wintergerst MWM, Sassmannshausen M, Schmitz-Valckenberg S, Pfau M, Thiele S, Poor S, Leal S, Holz FG, Finger RP; MACUSTAR Consortium. Comparability of automated drusen volume measurements in age-related macular degeneration: a MACUSTAR study report. Sci Rep. 2022 Dec 19;12(1):21911. doi: 10.1038/s41598-022-26223-w.
PubMed 36535990Terheyden JH, Pondorfer SG, Behning C, Berger M, Carlton J, Rowen D, Bouchet C, Poor S, Luhmann UFO, Leal S, Holz FG, Butt T, Brazier JE, Finger RP; MACUSTAR consortium. Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration - a MACUSTAR study report. Br J Ophthalmol. 2023 Aug;107(8):1144-1150. doi: 10.1136/bjophthalmol-2021-320848. Epub 2022 Mar 30.
PubMed 35354561Terheyden JH, Behning C, Luning A, Wintergerst L, Basile PG, Tavares D, Melicio BA, Leal S, Weissgerber G, Luhmann UFO, Crabb DP, Tufail A, Hoyng C, Berger M, Schmid M, Silva R, Martinho CV, Cunha-Vaz J, Holz FG, Finger RP; MACUSTAR consortium. Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study. BMC Med Res Methodol. 2021 Mar 17;21(1):54. doi: 10.1186/s12874-021-01243-8.
PubMed 33731014Terheyden JH, Holz FG, Schmitz-Valckenberg S, Luning A, Schmid M, Rubin GS, Dunbar H, Tufail A, Crabb DP, Binns A, Sanchez CI, Hoyng C, Margaron P, Zakaria N, Durbin M, Luhmann U, Zamiri P, Cunha-Vaz J, Martinho C, Leal S, Finger RP; MACUSTAR consortium. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR. Trials. 2020 Jul 18;21(1):659. doi: 10.1186/s13063-020-04595-6.
PubMed 32682441
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT03349801
- Acronym / sponsor ID
- MACUSTAR / ECR-AMD-2017-13
- Conditions
- Age Related Macular Degeneration (AMD)
- Keywords
- iAMD, biomarker, clinical endpoint
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 718 participants (actual)
- Lead sponsor
- Frank G. HolzUniversity, hospital or other
- Collaborators
- Bayer, Moorfields Eye Hospital NHS Foundation Trust, Novartis Pharmaceuticals, Association for Innovation and Biomedical Research on Light and Image, City, University of London, European Clinical Research Infrastructure Network, La Fondation Voir et Entendre, Hoffmann-La Roche, Radboud University Medical Center, University of Sheffield, University College, London, Carl Zeiss Meditec AG, Innovative Medicines Initiative
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR
Detailed description
The purpose of the MACUSTAR clinical study is to develop novel clinical endpoints for clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (iAMD). Additional objectives are to characterize the visual impairment in iAMD and its progression, as well as identify risk factors for progression to late stage AMD.
Moreover, MACUSTAR aims to optimize and standardize most relevant existing and/or rapidly available clinical endpoints in:
- visual functional outcomes measures
- structural outcomes measures
- patient reported outcomes measures (PROMs)
The study will be composed by two parts:
- a cross-sectional part to technically evaluate the functional and structural outcome measures to support a biomarker qualification by regulatory authorities and payers; and
- a longitudinal part to assess the prognostic power of changes in retinal sensitivity (as measured by microperimetry) for progression from iAMD to late AMD (nAMD and GA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no AMD | – | Other: No interventionNo interventions |
| early AMD | – | Other: No interventionNo interventions. |
| intermediate AMD | – | Other: No interventionNo interventions. |
| late AMD | – | Other: No interventionNo interventions. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include subjects with no AMD or normal aging changes and subjects with AMD classified in accordance with the international Beckman Classification. A total of 750 subjects will be recruited: * 300 subjects will participate in the Cross-sectional part: * 50 with normal aging changes, no AMD * 50 with early AMD, * 50 with late AMD * 150 with iAMD * 650 subjects will participate in the longitudinal part: * 600 iAMD * 50 early AMD
Key inclusion criteria (19 listed)
- General Inclusion criteria (applicable to all groups)
- Male and female subjects.
- Aged 55 - 85 years at baseline.
- Able and willing to provide written informed consent and to comply with the study protocol visits and assessments.
- Intermediate AMD
Key exclusion criteria (27 listed)
- General Exclusion criteria (applicable to all groups)
- Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator.
- Severe ptosis, extraocular motility restriction or head tremor preventing adequate fundus visualization in the opinion of the investigator.
- Any signs of nAMD or GA (does not apply to the late AMD group).
- Any concurrent intraocular condition in the study eye (e. g. glaucoma or cataract) that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAccording to clinical practice. | Other | early AMD, intermediate AMD, late AMD, no AMD |
Primary outcome
Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart
Time frame: 3 years from baseline
standard parameter, tested for comparison (reference variable)
Mean change from baseline in scotopic and mesopic microperimetry sensitivity
Time frame: 3 years from baseline
Mean change from baseline in low luminance visual acuity (LLVA)
Time frame: 3 years from baseline
Mean change from baseline in vanishing optotypes visual acuity (VA)
Time frame: 3 years from baseline
Mean change from baseline in low luminance deficit (LLD)
Time frame: 3 years from baseline
LLD = BCVA-LLVA
Mean change from baseline in absolute rod threshold of the dark adaptation test
Time frame: 3 years from baseline
Mean change from baseline in rod intercept time of the dark adaptation test
Time frame: 3 years from baseline
Proportion of subjects with progression in dark adaptation deficit beyond coefficient of repeatability structural
Time frame: 3 years from baseline
Mean change from baseline in the cube root of drusen volume by spectral-domain optical coherence tomography (SD-OCT)
Time frame: 3 years from baseline
Mean change from baseline in retinal thickness by spectral-domain optical coherence tomography (SD-OCT)
Time frame: 3 years from baseline
Focal pigmentary changes captured by colour fundus photography (CFP)
Time frame: 3 years from baseline
Presence of refractile deposits
Time frame: 3 years from baseline
Presence of intraretinal cystoid spaces
Time frame: 3 years from baseline
Presence of localized retinal pigment epithelium (RPE) hypertransmission
Time frame: 3 years from baseline
Presence of localized disruption of ellipsoid zone
Time frame: 3 years from baseline
Presence of localized subsidence of the outer plexiform layer and the inner nuclear layer
Time frame: 3 years from baseline
Presence of hyporeflective wedge-shaped bands
Time frame: 3 years from baseline
Presence of reticular drusen/subretinal drusenoid deposits and associated local changes as determined by multimodal imaging
Time frame: 3 years from baseline
Changes in localized fundus autofluorescence signal alterations
Time frame: 3 years from baseline
Proportion of subjects with reduction in drusen volume
Time frame: 3 years from baseline
Proportion of subjects with study eye that progressed to geogrphic atrophy (GA) and/or neovascular age-related macular degeneration (nAMD)
Time frame: 3 years from baseline
Proportion of subjects with conversions to late AMD detected with fluorescein angiography (FA) that could be detected with OCT-A (at equipped sites)
Time frame: 3 years from baseline
Presence of quiescent choroidal neovascularisation (CNV) as assessed by optical coherence tomography angiography (OCT-A) (at equipped sites)
Time frame: 3 years from baseline
OCT-A findings (at equipped sites)
Time frame: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the vision impairment in low luminance (VILL) questionnaire, including the domains of reading & accessing information
Time frame: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of Orientation & mobility (incl. driving)
Time frame: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of safety
Time frame: 3 years from baseline
Mean change from baseline in patient-reported low luminance visual functioning, as measured by the VILL questionnaire, including the domains of socio-emotional well-being
Time frame: 3 years from baseline
Change in utility index from baseline as measure by the patient-reported outcome measure (PROM) utility index
Time frame: 3 years from baseline
Mean change from baseline in patient-reported health status and utility using the EQ-5D-5L questionnaire (EuroQol Group)
Time frame: 3 years from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 42918418Goerdt L, Bessaheken D, Terheyden JH, Thiele S, Basten V, Behning C, Luhmann U, Leal S, Moll KP, Zakaria N, Schmid M, Finger RP, Holz FG, Schmitz-Valckenberg S, Sassmannshausen M; MACUSTAR Consortium. Longitudinal analysis of structural biomarkers for disease progression in intermediate age-related macular degeneration: a MACUSTAR study report. Ophthalmol Retina. 2026 Oct 23:S2468-6530(26)00539-7. doi: 10.1016/j.oret.2026.10.005. Online ahead of print.
- Derived from this study: PubMed 42824051Vidal-Oliver L, Terheyden J, Behning C, Basten V, Kornau M, Schlosser L, Luhmann UFO, Moll KP, Zakaria N, Leal S, Schmid M, Valckenberg SS, Holz F, Finger RP, Sassmannshausen M; MACUSTAR consortium. Cuticular Drusen and the Risk of Progression to Late Age-Related Macular Degeneration: A MACUSTAR Study Report. Ophthalmol Sci. 2026 Aug 18;6(10):101375. doi: 10.1016/j.xops.2026.101375. eCollection 2026 Oct.
- Derived from this study: PubMed 40294859Rowen D, Carlton J, McDool E, Holz FG, Zakaria N, Terheyden JH, Finger RP; MACUSTAR Consortium. Psychometric Performance of a New Condition-Specific Preference-Weighted Measure, Vision Impairment in Low Luminance-Utility Index, and EQ-5D-5L in Patients With Age-Related Macular Degeneration: A MACUSTAR Study Report. Value Health. 2025 Jul;28(7):1082-1090. doi: 10.1016/j.jval.2025.04.2155. Epub 2025 Apr 26.
- Derived from this study: PubMed 39910281Terheyden JH, Dunbar HMP, Schmitz-Valckenberg S, Behning C, Martinho C, Luhmann UFO, Sassmannshausen M, Luning A, Miliu A, Aires ID, Basile PG, Batuca J, Schmid M, Moll KP, Zakaria N, Tufail A, Binns A, Crabb DP, Leal S, Finger RP, Holz FG; MACUSTAR consortium. Validating candidate endpoints for intermediate age-related macular degeneration trials in a multi-centre setting-lessons from the MACUSTAR study. Eye (Lond). 2025 Apr;39(6):1031-1039. doi: 10.1038/s41433-024-03568-2. Epub 2025 Feb 5.
- Derived from this study: PubMed 38369283Rowen D, Carlton J, Terheyden JH, Finger RP, Wickramasekera N, Brazier J; MACUSTAR Consortium. Development and Valuation of a Preference-Weighted Measure in Age-Related Macular Degeneration From the Vision Impairment in Low Luminance Questionnaire: A MACUSTAR Report. Value Health. 2024 May;27(5):642-654. doi: 10.1016/j.jval.2024.02.001. Epub 2024 Feb 17.
- Derived from this study: PubMed 36563964Sassmannshausen M, Behning C, Weinz J, Goerdt L, Terheyden JH, Chang P, Schmid M, Poor SH, Zakaria N, Finger RP, Holz FG, Pfau M, Schmitz-Valckenberg S, Thiele S; MACUSTAR Consortium Members. Characteristics and Spatial Distribution of Structural Features in Age-Related Macular Degeneration: A MACUSTAR Study Report. Ophthalmol Retina. 2023 May;7(5):420-430. doi: 10.1016/j.oret.2022.12.007. Epub 2022 Dec 20.
- Derived from this study: PubMed 36535990Garzone D, Terheyden JH, Morelle O, Wintergerst MWM, Sassmannshausen M, Schmitz-Valckenberg S, Pfau M, Thiele S, Poor S, Leal S, Holz FG, Finger RP; MACUSTAR Consortium. Comparability of automated drusen volume measurements in age-related macular degeneration: a MACUSTAR study report. Sci Rep. 2022 Dec 19;12(1):21911. doi: 10.1038/s41598-022-26223-w.
- Derived from this study: PubMed 35354561Terheyden JH, Pondorfer SG, Behning C, Berger M, Carlton J, Rowen D, Bouchet C, Poor S, Luhmann UFO, Leal S, Holz FG, Butt T, Brazier JE, Finger RP; MACUSTAR consortium. Disease-specific assessment of Vision Impairment in Low Luminance in age-related macular degeneration - a MACUSTAR study report. Br J Ophthalmol. 2023 Aug;107(8):1144-1150. doi: 10.1136/bjophthalmol-2021-320848. Epub 2022 Mar 30.
- Derived from this study: PubMed 33731014Terheyden JH, Behning C, Luning A, Wintergerst L, Basile PG, Tavares D, Melicio BA, Leal S, Weissgerber G, Luhmann UFO, Crabb DP, Tufail A, Hoyng C, Berger M, Schmid M, Silva R, Martinho CV, Cunha-Vaz J, Holz FG, Finger RP; MACUSTAR consortium. Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study. BMC Med Res Methodol. 2021 Mar 17;21(1):54. doi: 10.1186/s12874-021-01243-8.
- Derived from this study: PubMed 32682441Terheyden JH, Holz FG, Schmitz-Valckenberg S, Luning A, Schmid M, Rubin GS, Dunbar H, Tufail A, Crabb DP, Binns A, Sanchez CI, Hoyng C, Margaron P, Zakaria N, Durbin M, Luhmann U, Zamiri P, Cunha-Vaz J, Martinho C, Leal S, Finger RP; MACUSTAR consortium. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR. Trials. 2020 Jul 18;21(1):659. doi: 10.1186/s13063-020-04595-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Holz, Prof. Dr. med. principal investigator
University Hospital, Bonn
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration (AMD), run by Frank G. Holz at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Italy, United Kingdom, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in best corrected visual acuity (BCVA) using an early treatment diabetic retinopathy study (ETDRS) chart (time frame: 3 years from baseline). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03349801, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.