Age-Related Macular DegenerationNCT06125977
Impact of Non-Exudative Type 1 MNV on AMD Progression
An observational study of Age-Related Macular Degeneration and Neovascularization, Choroidal, run by University of Utah at 1 site in United States.
Trial summary
The overall goal of the proposed research project is to provide evidence that a specific subtype of neovascularization that may develop in eyes with age-related macular degeneration (AMD) prevents vision loss. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Neovascularization, Choroidal
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to Aug 2027
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Patients with AMD.
Who may be able to join
- Males and females aged 50 years and older of all ethnicities.
- AMD in at least one eye (study eye).
- Type 1 macular neovascularization (MNV) in the study eye (to be confirmed by UREAD Reading Center at the Screening and Baseline Visit):
- Localized presence of a dense vascular network between Bruch's membrane and retinal pigment epithelium (RPE) on optical coherence tomography angiography (OCT-A) and a double-layer / shallow irregular RPE elevation (SIRE) sign on structural OCT.
- MNV lesion does not exceed the image frame of the 9x9 OCT-A scan.
- Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging and fundus-controlled perimetry (FCP) testing.
- Ability to comply with study protocol timelines.
Who cannot join
- Intermediate AMD group (original cohort): Exclusion criteria 1. - 11. apply. Atrophic AMD and/or previous treatment group (extended cohort): Exclusion criteria 4. - 11. apply.
- Atrophy in the study eye defined as:
- Complete RPE and outer retinal atrophy (cRORA) on OCT with homogeneous choroidal hypertransmission
- Absence of the RPE band measuring > 250 microns
- Evidence of overlying photoreceptor degeneration whose features include outer nuclear layer thinning, external limiting membrane loss, and ellipsoid zone or interdigitation zone loss
- Signs of exudation in the study eye requiring therapeutic intervention at the discretion of the investigator; NOTE: minimally exudative lesions in the study eye that do not require therapeutic interventions are no exclusion criterion.
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- Any history of treatment of exudative MNV in the study eye (e.g. type 1, type 2, mixed, polypoidal choroidal vasculopathy, and retinal angiomatous proliferation); NOTE: Non-exudative or minimally exudative type 1 MNV in the study eye, that does not require therapeutic intervention at the discretion of the investigator, is NOT and exclusion criterion; non-exudative or exudative MNV in the fellow eye is not an exclusion criterion. Fellow-eyes may receive treatment of exudative MNV as part of clinical care.
- Any disease/disorder other than AMD in the study eye at the time of inclusion (e.g. monogenic retinal diseases, diabetic retinopathy, retinal detachment, previous retinal surgeries, myopic degeneration), uncontrolled glaucoma with IP of higher than 30 mmHg (despite current pharmacological or non-pharmacological treatment) and uveitis.
- History of central retinal laser treatment, including photodynamic therapy (PDT) and subthreshold laser treatment for AMD in the study eye.
- Cataract surgery in the study eye within the last three months prior to enrollment. YAG capsulotomy in the study eye within the last 2 weeks prior to enrollment.
- Current or previous participation in clinical trials investigating drugs or supplements in AMD (except vitamins and minerals), if, in the opinion of the investigator, this affects the outcome of the study.
- Current or previous participation (less than 3 months from termination of participation) in clinical trials investigating drugs or supplements in diseases other than AMD, if, in the opinion of the investigator, this affects the outcome of the study.
- Any concurrent ocular condition in the study eye (e.g. cataracts) that, in the opinion of the investigator, requires medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or, if allow to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of best-corrected visual acuity during the study period.
- Concomitant diseases that in the opinion of the investigator would make adherence to the examination schedule difficult of unlikely (e.g. personality disorder, chronic alcoholism, Alzheimer's Disease, drug abuse).
- Evidence of significantly uncontrolled concomitant diseases at the discretion of the investigator (e.g. cardiovascular, neurological, pulmonary, renal, hepatic, endocrine gastrointestinal disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Non-Exudative Type 1 Macular Neovascularization (MNV) on Age-related Macular Degeneration (AMD) Progression
The overall goal of the proposed research project is to provide evidence that a specific subtype of neovascularization that may develop in eyes with age-related macular degeneration (AMD) prevents vision loss.
This concept challenges the current view that the development of neovascularizations in AMD represents a harmful event in general. Notably, before the era of anti-vascular endothelial growths factor (VEGF) therapy, destruction and surgical removal of neovascular membranes have been tested as treatment options for neovascular AMD.
Read more
This research project aims to substantiate the hypothesis that type 1 macular neovascularization (MNV) is intrinsically protective, in sense of a positive response to the degenerative processes in AMD. This concept has actually been proposed by pathologists decades ago but has not been systematically investigated in vivo.
With the immense advances in retinal imaging, 'sub-clinical', non-exudative type 1 MNVs that are located beneath the retinal pigment epithelium (RPE) can now be detected non-invasively and characterized in vivo. There is currently a growing body of evidence that photoreceptor and RPE degeneration is indeed slowed down in eyes exhibiting type 1 MNV. However, the proof of a direct protective effect of non-exudative type 1 MNV on visual function in AMD is lacking.
Here, the aim is to demonstrate relative preservation of function along with preserved structure in the immediate vicinity of type 1 MNV, while there is progressive loss of sensitivity and degeneration in the surrounding tissue.
- Keywords
- Non-exudative type 1 macular neovascularization (MNV)
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Intermediate AMD group, Original Cohort | |
| Cohort 2 | Atrophic AMD and/or previous treatment group, Extended Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in mesopic retinal sensitivity assessed by Fundus-controlled Perimetry (FCP).
This sensitivity change will be compared between (I) retinal areas colocalizing with non-exudative type 1 MNV (test-point group I) and (II) retinal areas without evidence of MNV (testpoint group II).
Measured: At months 36 from baseline.
Secondary outcomes (2)
Changes over time of qualitative and quantitative structural biomarkers for disease progression.
These changes will be compared between (I) retinal areas co-localizing with non-exudative type 1 MNV and (II) retinal areas without evidence of MNV.
Measured: At months 36 from baseline.
Mean change over time in dark-adapted retinal sensitivity assessed by Fundus-controlled Perimetry (FCP).
This sensitivity change will be compared between (I) retinal areas colocalizing with non-exudative type 1 MNV (test-point group I) and (II) retinal areas without evidence of MNV (testpoint group II).
Measured: At months 36 from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Jan 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Monika Fleckenstein, University of Utah
- Investigators
- Monika Fleckenstein, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125977
- Sponsor's protocol ID
- IRB_00151913
- Other IDs
- 1R01EY033365-01A1
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Non-Exudative Type 1 Macular Neovascularization (MNV) on Age-related Macular Degeneration (AMD) Progression
- ClinicalTrials.gov ID
- NCT06125977
- Acronym / sponsor ID
- IRB_00151913
- Keywords
- Non-exudative type 1 macular neovascularization (MNV)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
The overall goal of the proposed research project is to provide evidence that a specific subtype of neovascularization that may develop in eyes with age-related macular degeneration (AMD) prevents vision loss.
This concept challenges the current view that the development of neovascularizations in AMD represents a harmful event in general. Notably, before the era of anti-vascular endothelial growths factor (VEGF) therapy, destruction and surgical removal of neovascular membranes have been tested as treatment options for neovascular AMD.
This research project aims to substantiate the hypothesis that type 1 macular neovascularization (MNV) is intrinsically protective, in sense of a positive response to the degenerative processes in AMD. This concept has actually been proposed by pathologists decades ago but has not been systematically investigated in vivo.
With the immense advances in retinal imaging, 'sub-clinical', non-exudative type 1 MNVs that are located beneath the retinal pigment epithelium (RPE) can now be detected non-invasively and characterized in vivo. There is currently a growing body of evidence that photoreceptor and RPE degeneration is indeed slowed down in eyes exhibiting type 1 MNV. However, the proof of a direct protective effect of non-exudative type 1 MNV on visual function in AMD is lacking.
Here, the aim is to demonstrate relative preservation of function along with preserved structure in the immediate vicinity of type 1 MNV, while there is progressive loss of sensitivity and degeneration in the surrounding tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Intermediate AMD group, Original Cohort |
| Cohort 2 | – | –Atrophic AMD and/or previous treatment group, Extended Cohort |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with AMD.
Key inclusion criteria (7 listed)
- Males and females aged 50 years and older of all ethnicities.
- AMD in at least one eye (study eye).
- Type 1 macular neovascularization (MNV) in the study eye (to be confirmed by UREAD Reading Center at the Screening and Baseline Visit):
- Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging and fundus-controlled perimetry (FCP) testing.
- Ability to comply with study protocol timelines.
Key exclusion criteria (15 listed)
- Intermediate AMD group (original cohort): Exclusion criteria 1. - 11. apply. Atrophic AMD and/or previous treatment group (extended cohort): Exclusion criteria 4. - 11. apply.
- Atrophy in the study eye defined as:
- Signs of exudation in the study eye requiring therapeutic intervention at the discretion of the investigator; NOTE: minimally exudative lesions in the study eye that do not require therapeutic interventions are no exclusion criterion.
- Any history of treatment of exudative MNV in the study eye (e.g. type 1, type 2, mixed, polypoidal choroidal vasculopathy, and retinal angiomatous proliferation); NOTE: Non-exudative or minimally exudative type 1 MNV in the study eye, that does not require therapeutic intervention at the discretion of the investigator, is NOT and exclusion criterion; non-exudative or exudative MNV in the fellow eye is not an exclusion criterion. Fellow-eyes may receive treatment of exudative MNV as part of clinical care.
- Any disease/disorder other than AMD in the study eye at the time of inclusion (e.g. monogenic retinal diseases, diabetic retinopathy, retinal detachment, previous retinal surgeries, myopic degeneration), uncontrolled glaucoma with IP of higher than 30 mmHg (despite current pharmacological or non-pharmacological treatment) and uveitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean change in mesopic retinal sensitivity assessed by Fundus-controlled Perimetry (FCP).
Time frame: At months 36 from baseline.
This sensitivity change will be compared between (I) retinal areas colocalizing with non-exudative type 1 MNV (test-point group I) and (II) retinal areas without evidence of MNV (testpoint group II).
2 secondary outcomes
Changes over time of qualitative and quantitative structural biomarkers for disease progression.
Time frame: At months 36 from baseline.
Mean change over time in dark-adapted retinal sensitivity assessed by Fundus-controlled Perimetry (FCP).
Time frame: At months 36 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 17 Dec 2025.
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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.
Monika Fleckenstein, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration and Neovascularization, Choroidal, run by University of Utah at 1 site in United States.
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 7 inclusion and 15 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 in mesopic retinal sensitivity assessed by Fundus-controlled Perimetry (FCP). (time frame: At months 36 from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.