Macular DegenerationPhase 4ARIESNCT02581891
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
A Phase 4 study testing Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 39 sites in 8 countries.
Trial summary
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 19 Nov 2015to 26 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years of age.
- Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
- ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
- The area of CNV must occupy at least 50% of the total lesion.
Who cannot join
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
- Prior treatment with anti-VEGF agents as follows:
- Prior treatment with anti-VEGF therapy in the study eye is not allowed
- Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
- Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
Show all 11Show fewer
- Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
- Scar or fibrosis making up >50% of the total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
Hungary9 sites
Study site
Budapest, 1062
Study site
Budapest, 1085
Study site
Budapest, 1106
Study site
Budapest, 1115
Study site
Budapest, 1125
Study site
Budapest, 1133
Study site
Debrecen, 4032
Study site
Pécs, 7621
Study site
Szombathely, 9700
Germany8 sites
Study site
Berlin, 10713
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Chemnitz, Saxony, 09116
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study site
Hanover, Lower Saxony, 30625
Study site
Sulzbach, Saarland, 66280
Study site
Tübingen, Baden-Wurttemberg, 72076
Australia5 sites
Study site
East Melbourne, Victoria, 3002
Study site
Launceston, 7249
Study site
Strathfield, New South Wales, 2135
Study site
Sydney, New South Wales, 2000
Study site
Westmead, New South Wales, 2145
United Kingdom5 sites
Study site
Bristol, BS12LX
Study site
Canterbury, Kent, CT1 3NG
Study site
Liverpool, L7 8XP
Study site
London, EC1V2PD
Study site
Oxford, OX3 9DU
Italy4 sites
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20157
Study site
Padova, Veneto, 35128
Study site
Rome, Lazio, 00198
Canada3 sites
Study site
Boisbriand, Quebec, J7H1S6
Study site
Hamilton, Ontario, L8G 5E4
Study site
Ottawa, Ontario, K2B7E9
Spain3 sites
Study site
Madrid
Study site
Oviedo, Principality of Asturias, 33012
Study site
Zaragoza, 50009
About this study
Official title: Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
Read the detailed description
The T\&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.
To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T\&E regimen with intravitreal aflibercept in subjects with nAMD.
- Conditions
- Macular Degeneration
- Being tested
- Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Neovascular age-related macular degeneration, nAMD)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria
Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria
| Study group | Role | What they receive |
|---|---|---|
| Early-start T&E / Arm 1 | Experimental | Early-start T\&E arm: test group, early treatment individualization Receives: Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) |
| Late-start T&E / Arm 2 | Active comparator | Late-start T\&E arm; per label, control group, treatment individualization after Year 1 Receives: Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA as Measured by the ETDRS Letter Score
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Measured: From Week 16 to Week 104
Secondary outcomes (8)
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Measured: at Week 104
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Measured: from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Measured: At week 52
Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline
Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
Measured: At Week 52 and Week 104
Change in Central Retinal Thickness (CRT)
CRT were evaluated using spectral domain Optical coherence tomograph (OCT).
Measured: From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104
Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104
Measured: At Week 52 and Week 104
Duration of Last Treatment Interval
Measured: Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
Measured: at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start19 Nov 2015
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581891
- Sponsor's protocol ID
- 17508
- Other IDs
- 2014-003132-39, 2014
- Acronym
- ARIES
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2015
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wolf S, Holz FG, Midena E, Souied EH, Lambrou G, Machewitz T, Allmeier H, Mitchell P; ARIES Study Investigators. Patients with Neovascular Age-Related Macular Degeneration Requiring Intensive Intravitreal Aflibercept Treatment: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Oct;11(5):1793-1803. doi: 10.1007/s40123-022-00541-8. Epub 2022 Jul 12.
PubMed 35821380Chaudhary V, Holz FG, Wolf S, Midena E, Souied EH, Allmeier H, Lambrou G, Machewitz T, Mitchell P; ARIES study investigators. Association Between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Jun;11(3):1119-1130. doi: 10.1007/s40123-022-00491-1. Epub 2022 Mar 18.
PubMed 35303285Tuerksever C, Somfai GM, Oesch S, Machewitz T, Hasler PW, Zweifel S. Hypothetical Switch of Anti-Vascular Endothelial Growth Factor in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Apr;11(2):613-627. doi: 10.1007/s40123-021-00448-w. Epub 2022 Jan 23.
PubMed 35066801Krieger N, Chen JT, Testa C, Diez Roux A, Tilling K, Watkins S, Simpkin AJ, Suderman M, Davey Smith G, De Vivo I, Waterman PD, Relton C. Use of Correct and Incorrect Methods of Accounting for Age in Studies of Epigenetic Accelerated Aging: Implications and Recommendations for Best Practices. Am J Epidemiol. 2023 May 5;192(5):800-811. doi: 10.1093/aje/kwad025.
PubMed 36721372Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S; ARIES study investigators. EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial. Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.
PubMed 33782365
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
- ClinicalTrials.gov ID
- NCT02581891
- Acronym / sponsor ID
- ARIES / 17508
- Conditions
- Macular Degeneration
- Keywords
- Neovascular age-related macular degeneration, nAMD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
Detailed description
The T\&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.
To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T\&E regimen with intravitreal aflibercept in subjects with nAMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-start T&E / Arm 1 | Experimental | Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)Early-start T\&E arm: test group, early treatment individualization |
| Late-start T&E / Arm 2 | Active comparator | Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)Late-start T\&E arm; per label, control group, treatment individualization after Year 1 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 50 years of age.
- Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
- ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
- The area of CNV must occupy at least 50% of the total lesion.
Key exclusion criteria (11 listed)
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
- Prior treatment with anti-VEGF agents as follows:
- Prior treatment with anti-VEGF therapy in the study eye is not allowed
- Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
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 |
|---|---|---|
| Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria | Drug | Early-start T&E / Arm 1 |
| Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria | Drug | Late-start T&E / Arm 2 |
Primary outcome
Change in BCVA as Measured by the ETDRS Letter Score
Time frame: From Week 16 to Week 104
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
8 secondary outcomes
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline
Time frame: at Week 104
Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52
Time frame: from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52
Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline
Time frame: At week 52
Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline
Time frame: At Week 52 and Week 104
Change in Central Retinal Thickness (CRT)
Time frame: From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104
Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104
Time frame: At Week 52 and Week 104
Duration of Last Treatment Interval
Time frame: Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination
Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval
Time frame: at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35821380Wolf S, Holz FG, Midena E, Souied EH, Lambrou G, Machewitz T, Allmeier H, Mitchell P; ARIES Study Investigators. Patients with Neovascular Age-Related Macular Degeneration Requiring Intensive Intravitreal Aflibercept Treatment: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Oct;11(5):1793-1803. doi: 10.1007/s40123-022-00541-8. Epub 2022 Jul 12.
- Results publication: PubMed 35303285Chaudhary V, Holz FG, Wolf S, Midena E, Souied EH, Allmeier H, Lambrou G, Machewitz T, Mitchell P; ARIES study investigators. Association Between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Jun;11(3):1119-1130. doi: 10.1007/s40123-022-00491-1. Epub 2022 Mar 18.
- Results publication: PubMed 35066801Tuerksever C, Somfai GM, Oesch S, Machewitz T, Hasler PW, Zweifel S. Hypothetical Switch of Anti-Vascular Endothelial Growth Factor in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Apr;11(2):613-627. doi: 10.1007/s40123-021-00448-w. Epub 2022 Jan 23.
- Derived from this study: PubMed 36721372Krieger N, Chen JT, Testa C, Diez Roux A, Tilling K, Watkins S, Simpkin AJ, Suderman M, Davey Smith G, De Vivo I, Waterman PD, Relton C. Use of Correct and Incorrect Methods of Accounting for Age in Studies of Epigenetic Accelerated Aging: Implications and Recommendations for Best Practices. Am J Epidemiol. 2023 May 5;192(5):800-811. doi: 10.1093/aje/kwad025.
- Derived from this study: PubMed 33782365Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S; ARIES study investigators. EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial. Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.
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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.
Bayer Study Director study director
Bayer
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 39 sites in 8 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Hungary, Germany, Australia, United Kingdom, Italy and 3 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in BCVA as Measured by the ETDRS Letter Score (time frame: From Week 16 to Week 104). 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 NCT02581891, which also lists 5 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 8 Nov 2023.