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Diabetic Macular EdemaPhase 2/3PHOTONNCT04429503

Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

A Phase 2/3 study testing aflibercept and High-dose aflibercept in people with Diabetic Macular Edema and Type 1 Diabetes Mellitus, run by Regeneron Pharmaceuticals at 138 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: To determine the effect of HD vs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aflibercept and High-dose aflibercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
138 sitesin 8 countries
Study dates
29 Jun 2020to 18 Jun 2024
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diabetic macular edema (DME) with central involvement in the study eye
  • Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide informed consent signed by study participant or legally acceptable representative
  • Extension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.

Who cannot join

  • Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  • Active proliferative diabetic retinopathy in the study eye
  • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
  • Treatment with ocriplasmin (JETREA®) in the study eye at any time
  • NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Trial locations and contacts

138 sites in 8 countries.

138 sites in 8 countries

United States84 sites

  • Regeneron Study Site

    ‘Aiea, Hawaii, 96701

  • Regeneron Study Site

    Abilene, Texas, 79606

  • Regeneron Study Site

    Arcadia, California, 91006

  • Regeneron Study Site

    Asheville, North Carolina, 28803

  • Regeneron Study Site

    Augusta, Georgia, 30909

  • Regeneron Study Site

    Baltimore, Maryland, 21209

  • Regeneron Study Site

    Beachwood, Ohio, 44122

  • Regeneron Study Site

    Beaufort, South Carolina, 29902

  • Regeneron Study Site

    Bellaire, Texas, 77401

  • Regeneron Study Site

    Bethlehem, Pennsylvania, 18017

  • Regeneron Study Site

    Beverly Hills, California, 90211

  • Regeneron Study Site

    Bloomfield, New Jersey, 07003

  • Regeneron Study Site

    Boston, Massachusetts, 02114

  • Regeneron Study Site

    Campbell, California, 95008

  • Regeneron Study Site

    Carmel, Indiana, 46290

  • Regeneron Study Site

    Charlotte, North Carolina, 28210

  • Regeneron Study Site

    Cincinnati, Ohio, 45202

  • Regeneron Study Site

    Cincinnati, Ohio, 45242

  • Regeneron Study Site

    Clearwater, Florida, 33761

  • Regeneron Study Site

    Cleveland, Ohio, 44130

  • Regeneron Study Site

    Colorado Springs, Colorado, 80909

  • Regeneron Study Site

    Dublin, Ohio, 43016

  • Regeneron Study Site

    Durango, Colorado, 81301

  • Regeneron Study Site

    Edison, New Jersey, 08820

  • Regeneron Study Site

    Edmond, Oklahoma, 73013

  • Regeneron Study Site

    Encino, California, 91436

  • Regeneron Study Site

    Fairfax, Virginia, 22031

  • Regeneron Study Site

    Fort Lauderdale, Florida, 33308

  • Regeneron Study Site

    Fort Myers, Florida, 33912

  • Regeneron Study Site

    Fullerton, California, 92835

  • Regeneron Study Site

    Germantown, Tennessee, 38138

  • Regeneron Study Site

    Great Neck, New York, 11021

  • Regeneron Study Site

    Hagerstown, Maryland, 21740

  • Regeneron Study Site

    Henderson, Nevada, 89052

  • Regeneron Study Site

    Huntington Beach, California, 92647

  • Regeneron Study Site

    Jacksonville, Florida, 32216

  • Regeneron Study Site

    Kingston, Pennsylvania, 18704

  • Regeneron Study Site

    Knoxville, Tennessee, 37922

  • Regeneron Study Site

    Ladson, South Carolina, 29456

  • Regeneron Study Site

    Lakeland, Florida, 33805

  • Regeneron Study Site

    Lakewood, Colorado, 80228

  • Regeneron Study Site

    Largo, Florida, 33770

  • Regeneron Study Site

    Liverpool, New York, 13088

  • Regeneron Study Site

    Long Beach, California, 90807

  • Regeneron Study Site 1

    Marietta, Georgia, 30060

  • Regeneron Study Site 2

    Marietta, Georgia, 30060

  • Regeneron Study Site

    Melbourne, Florida, 32901

  • Regeneron Study Site

    Miami, Florida, 33126

  • Regeneron Study Site

    Monroeville, Pennsylvania, 15146

  • Regeneron Study Site

    Morgantown, West Virginia, 26506

  • Regeneron Study Site

    Nashville, Tennessee, 37203

  • Regeneron Study Site

    New York, New York, 11221

  • Regeneron Study Site

    Norfolk, Virginia, 23502

  • Regeneron Study Site

    Oak Forest, Illinois, 60452

  • Regeneron Study Site

    Oceanside, New York, 11572

  • Regeneron Study Site

    Orlando, Florida, 32806

  • Regeneron Study Site

    Palo Alto, California, 94303

  • Regeneron Study Site

    Pasadena, California, 91107

  • Regeneron Study Site

    Phoenix, Arizona, 85021

  • Regeneron Study Site

    Pinellas Park, Florida, 33782

  • Regeneron Study Site

    Plantation, Florida, 33324

  • Regeneron Study Site

    Portland, Oregon, 97225

  • Regeneron Study Site

    Poway, California, 92064

  • Regeneron Study Site

    Rancho Cordova, California, 95670

  • Regeneron Study Site

    Rapid City, South Dakota, 57701

  • Regeneron Study Site

    Riverside, California, 92505

  • Regeneron Study Site

    Royal Oak, Michigan, 48073

  • Regeneron Study Site 1

    Salt Lake City, Utah, 84107

  • Regeneron Study Site 2

    San Antonio, Texas, 78240

  • Regeneron Study Site

    Shawnee Mission, Kansas, 66204

  • Regeneron Study Site

    Shirley, New York, 02114

  • Regeneron Study Site

    Southaven, Mississippi, 38671

  • Regeneron Study Site

    Springfield, Illinois, 62703

  • Regeneron Study Site

    Springfield, Illinois, 62704

  • Regeneron Study Site

    St. Petersburg, Florida, 33711

  • Regeneron Study Site

    Stuart, Florida, 34994

  • Regeneron Study Site

    Teaneck, New Jersey, 07666

  • Regeneron Study Site

    The Woodlands, Texas, 77384

  • Regeneron Study Site

    Torrance, California, 90509

  • Regeneron Study Site

    Tulsa, Oklahoma, 74114

  • Regeneron Study Site

    Waterford, Connecticut, 06385

  • Regeneron Study Site

    West Columbia, South Carolina, 29169

  • Regeneron Study Site

    Willow Park, Texas, 76087

  • Regeneron Study Site

    Winter Haven, Florida, 33880

Other trials in United States

Japan31 sites

  • Regeneron Study Site

    Chiyoda-ku, Tokyo, 101-8309

  • Regeneron Study Site

    Fukuoka, 812-0011

  • Regeneron Study Site

    Fukuoka, 819-8585

  • Regeneron Study Site

    Hachiōji, Tokyo, 193-0998

  • Regeneron Study Site

    Hakodate, Hokkaido, 041-0851

  • Regeneron Study Site

    Hirakata, Osaka, 573-1191

  • Regeneron Study Site

    Itabashi-ku, Tokyo, 173-0015

  • Regeneron Study Site

    Kagoshima, 890-8520

  • Regeneron Study Site

    Kashihara, Nara, 634-8522

  • Regeneron Study Site

    Kawasaki, Kanagawa, 216-8511

  • Regeneron Study Site

    Kita-gun, Kagawa-ken, 761-0793

  • Regeneron Study Site

    Kobe, Hyōgo, 650-0017

  • Regeneron Study Site

    Kōriyama, Fukushima, 963-8052

  • Regeneron Study Site

    Kurume, Fukuoka, 830-0011

  • Regeneron Study Site

    Matsumoto, Nagano, 390-8621

  • Regeneron Study Site

    Meguro-ku, Tokyo, 152-8902

  • Regeneron Study Site

    Mito, Ibaraki, 310-0845

  • Regeneron Study Site

    Nagakute, Aichi-ken, 480-1195

  • Regeneron Study Site

    Nagasaki, Nagasaki, 852-8501

  • Regeneron Study Site

    Nagoya, Aichi-ken, 466-8560

  • Regeneron Study Site

    Nagoya, Aichi-ken, 467-8602

  • Regeneron Study Site

    Osaka, 545-8586

  • Regeneron Study Site

    Saitama, 330-8553

  • Regeneron Study Site

    Shimotsuke-shi, Tochigi, 329-0498

  • Regeneron Study Site

    Susono, Shizuoka, 410-1102

  • Regeneron Study Site

    Tokorozawa, Saitama, 359-8513

  • Regeneron Study Site

    Tokushima, 770-8503

  • Regeneron Study Site

    Toride, Ibaraki, 302-0014

  • Regeneron Study Site

    Tsuchiura-shi, Ibaraki, 300-0817

  • Regeneron Study Site

    Ube, Yamaguchi, 755-8505

  • Regeneron Study Site

    Yoshida-Gun, Fukui, 910-1193

Other trials in Japan

Hungary9 sites

  • Regeneron Study Site

    Budapest, H-1085

  • Regeneron Study Site

    Budapest, H-1106

  • Regeneron Study Site

    Budapest, H-1133

  • Regeneron Study Site

    Budapest, H-1145

  • Regeneron Study Site

    Debrecen, H-4032

  • Regeneron Study Site 1

    Pécs, Baranya, H-7621

  • Regeneron Study Site

    Szeged, H-6720

  • Regeneron Study Site

    Szombathely, Vas County, H-9700

  • Regeneron Study Site

    Zalaegerszeg, Zala County, H-8900

Other trials in Hungary

Canada4 sites

  • Regeneron Study Site

    Calgary, Alberta, T2H 0C8

  • Regeneron Study Site

    Mississauga, Ontario, L4W 1W9

  • Regeneron Study Site

    North York, Ontario, M3C 0G9

  • Regeneron Study Site

    Sherbrooke, Quebec, J1G 2V4

Other trials in Canada

Czechia4 sites

  • Regeneron Study Site

    Pardubice, 530 02

  • Regeneron Study Site

    Prague, 100 34

  • Regeneron Study Site

    Prague, 128 08

  • Regeneron Study Site

    Prague, 150 00

Other trials in Czechia

Germany3 sites

  • Regeneron Study Site

    Göttingen, North Rhine-Westphalia, 37075

  • Regeneron Study Site

    Münster, North Rhine-Westphalia, 48145

  • Regeneron Study Site

    Neubrandenburg, Mecklenburg-Westfalen, 17036

Other trials in Germany

United Kingdom2 sites

  • Regeneron Study Site

    London, EC1V 2PD

  • Regeneron Study Site

    Sunderland, Tyne and Wear, SR2 9HP

Other trials in United Kingdom

Puerto Rico1 site

  • Regeneron Study Site

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
Being tested
aflibercept, High-dose aflibercept
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afliberceptDrug

    Also called EYLEA®, BAY86-5321

    Intravitreally (IVT) administered as a liquid formulation in a vial

  • High-dose afliberceptDrug

    Intravitreally (IVT) administered as a liquid formulation in a vial

Study groups in NCT04429503
Study groupRoleWhat they receive
aflibercept Q8Active comparatorAdministered every 8 weeks after a loading phase
Receives: Drug: aflibercept
High-Dose aflibercept Q12ExperimentalAdministered every 12 weeks after a loading phase
Receives: Drug: High-dose aflibercept
High-Dose aflibercept Q16ExperimentalAdministered every 16 weeks after a loading phase
Receives: Drug: High-dose aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

    Measured: Baseline, Week 48

Secondary outcomes (16)

  1. Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48

    The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.

    Measured: Baseline, Week 48

  2. Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study

    Measured: Baseline, Week 48

  3. Percentage of Participants With BCVA ≥69 Letters at Week 48

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

    Measured: At Week 48

  4. Percentage of Participants Without Fluid at Foveal Center at Week 48

    Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.

    Measured: At Week 48

  5. Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48

    Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).

    Measured: Baseline, Week 48

  6. Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48

    Leakage is the release of fluorescein dye from diseased retinal vessels.

    Measured: At Week 48

  7. Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score at Week 48

    Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).

    Measured: Baseline, Week 48

  8. Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48

    Concentrations of Free Aflibercept in Plasma by Time and Treatment Group

    Measured: Through Week 48

  9. Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)

    Measured: Baseline, Week 48

  10. Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)

    Measured: Baseline, Week 48

  11. Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60

    Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).

    Measured: Baseline, Week 60

  12. Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96

    Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported

    Measured: Through Week 96

  13. Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96

    A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.

    Measured: Through Week 96

  14. Number of Participants With Any Serious TEAE Through Week 96

    A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.

    Measured: Through Week 96

  15. Number of Participants With Any TEAE Through Week 156

    TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.

    Measured: Through Week 156

  16. Number of Participants With Any Serious TEAE Through Week 156

    Measured: Through Week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start29 Jun 2020
  3. Primary completion30 May 2022
  4. Study completion18 Jun 2024

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04429503
Sponsor's protocol ID
VGFTe-HD-DME-1934
Other IDs
2019-003643-30, 2019
Acronym
PHOTON
Status last verified
Jul 2025
First submitted
26 May 2020
Last updated
8 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication.

Publications

  • Loewenstein A, Schmidt-Ott U, Do DV, Lanzetta P, Leal S, Berliner AJ, Chu KW, Barakat MR, Ghorayeb G, Stewart MW, Spitzer MS, Zhang X, McCullough A, Tueckmantel C, Avila D, Morgan-Warren P, Brunck L, Dupljak A, Hymowitz M, Portnoy A, Gale R. Intraocular Pressure Outcomes with Intravitreal Aflibercept 8 mg: A 96-Week Pooled Analysis from PULSAR and PHOTON. Ophthalmol Ther. 2026 Jul;15(7):2441-2456. doi: 10.1007/s40123-026-01424-y. Epub 2026 Jun 13.

    PubMed 42287526

  • Suzuma K, Murata T, Shimura M, Yoshida S, Kishino G, Berliner AJ, Chu KW, Reed K, Vitti R, Cheng Y, Voronca D, Bhore R, Leal S, Morgan-Warren P, Schulze A, Schmidt-Ott U, Kobayashi M, Sakamoto T; PHOTON Investigators. Intravitreal aflibercept 8 mg in patients from Japan with diabetic macular edema: 48-week subgroup analysis of the PHOTON trial. Jpn J Ophthalmol. 2026 Jan;70(1):123-138. doi: 10.1007/s10384-025-01271-7. Epub 2025 Dec 26.

    PubMed 41452566

  • Do DV, Wykoff CC, Sivaprasad S, Brown DM, Boyer DS, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Cheng Y, Bhore R, Bai Z, Schmidt-Ott U, Schmelter T, Schulze A, Hasanbasic Z, Morgan-Warren PJ, Zhang X, Hirshberg B, Yancopoulos GD; PHOTON Investigators. Intravitreal Aflibercept 8 mg for Diabetic Macular Edema: Ninety-Six-Week Results from the Randomized Phase 2/3 PHOTON Trial. Ophthalmology. 2026 May;133(5):577-588. doi: 10.1016/j.ophtha.2025.10.028. Epub 2025 Nov 10.

    PubMed 41223900

  • Brown DM, Boyer DS, Do DV, Wykoff CC, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Rao R, Cheng Y, Sun W, Voronca D, Bhore R, Schmidt-Ott U, Schmelter T, Schulze A, Zhang X, Hirshberg B, Yancopoulos GD, Sivaprasad S; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 23;403(10432):1153-1163. doi: 10.1016/S0140-6736(23)02577-1. Epub 2024 Mar 7.

    PubMed 38461843

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing aflibercept and High-dose aflibercept in people with Diabetic Macular Edema and Type 1 Diabetes Mellitus, run by Regeneron Pharmaceuticals at 138 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 5 inclusion and 6 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 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Japan, Hungary, Canada, Czechia 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Nov 2023). 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 From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48 (time frame: Baseline, Week 48). 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 NCT04429503, which also lists 4 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 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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