A Phase 2/3 interventional study of Remigromig and Ranibizumab in Diabetic Macular Edema (DME), sponsored by EyeBiotech Ltd.. Active, not recruiting at 164 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by EyeBiotech Ltd. (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Treatment
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Among 276 studies in Macular Edema with a site in United States — 16 open to participants now, 33 under way, 11 of them phase 3. Macular Edema · United States.
Among the 276 studies in Macular Edema with a site in United States, this one is the 5th largest by enrollment of the 244 interventional ones that give a count, is one of 8 that started in 2025, is one of 7 in phase 2/3, reaches primary completion later than 14 of the 32 other live ones, and was the 261st registered.
758 studies on the registry are indexed under Macular Edema; 66 are open to participants now.
Browse Macular Edema studies →16 of the 276 studies in Macular Edema with a site in United States are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Israel and 1 more country
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Argentina, Australia and 1 more country
Ages 18+
Kodiak Sciences Inc · Sites in United States, Argentina
Ages 18+
Massachusetts Eye and Ear Infirmary · Sites in United States
Ages 18+
Boehringer Ingelheim · Sites in United States, Puerto Rico
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Macular Edema studies recruiting now, 31 (70%) set no upper age limit and 7 (16%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
276 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 74 · Phase 2 101 · Phase 3 57 · Phase 4 33
First in 1992; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,054 is above the median of 56 across 586 interventional studies indexed under Macular Edema.
Median enrollment 45 across the 244 interventional studies, 60 across the 30 observational. Of the 222 that completed or were terminated, 130 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
133 of 276 have an industry lead sponsor. The 10 most frequent:
This study is registered under EyeBiotech Ltd., one of the names counted as Merck & Co., Inc. Under that name alone:
EyeBiotech Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Merck & Co., Inc has 7 studies filed under Macular Edema — fewer than ten, so there is no comparison to draw.
12 of the studies in Macular Edema with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06957080Phase 3EyeBiotech Ltd.A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME | 2027-01-11 |
| NCT06996080Phase 3Kodiak Sciences IncA Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE | 2027-02 |
| NCT06990399Phase 3Kodiak Sciences IncA Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK | 2027-04 |
| NCT04108156Phase 3Hoffmann-La RocheA Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME | 2027-07-20 |
| NCT07449923Phase 3EyePoint Pharmaceuticals, Inc.CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME | 2027-10 |
Add all 12 to your calendar (.ics) → With an account.
Among the 276 studies in Macular Edema with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME).
In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME).
Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose remigromig, high dose remigromig, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remigromig Low Dose Treatment Arm
Drug: Remigromig
Remigromig High Dose Treatment Arm
Drug: Remigromig
Ranibizumab Treatment Arm
Drug: Ranibizumab
Remigromig is a humanized antibody formulated for intravitreal administration
Also known as: EYE103, Restoret
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
Also known as: Lucentis
Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.
Time frame: Baseline and Week 52
Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52
The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented.
Time frame: Baseline and Week 52
Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52
The Superiority Hypothesis: change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.
Time frame: Baseline and Week 52
Time to Absence of Diabetic Macular Edema (DME)
The time to absence of Diabetic Macular Edema (DME) defined as Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) of \<300 μm will be presented.
Time frame: Up to approximately Week 52
Time to Gaining ≥15 ETDRS Letters
The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.
Time frame: Up to approximately Week 52
Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24
The proportion of participants with resolution of macular leakage on fluorescein angiography (FA), defined as 0 to 1 mm\^2, at Week 24 will be presented.
Time frame: Up to approximately Week 24
Proportion of Participants without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52
The proportion of participants without intraretinal and subretinal fluid at the foveal center on Optical Coherence Tomography (OCT) at Week 52 will be presented.
Time frame: Up to approximately Week 52
Change from Baseline in Focal Area Zone (FAZ) area on Fluorescein Angiography (FA) at Week 52
The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented.
Time frame: Baseline and Week 52
Proportion of Participants Achieving 20/40 or Better BCVA at Week 52
The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.
Time frame: Up to approximately Week 52
Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic AE will be reported.
Time frame: Up to approximately 104 Weeks
Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic serious adverse event (SAE) will be reported.
Time frame: Up to approximately 104 Weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 104 Weeks
Showing the first 100 of 164 sites across 6 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Mar 2027 → Jan 2027 and completion Mar 2028 → Jan 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remigromig