NCT05919693CompletedPhase 1/2
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) Remigromig (EYE103) in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) Remigromig in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of remigromig (EYE103) in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of remigromig will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of remigromig will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 14 Jun 2023
- Start date
- 12 Jun 2023
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- EyeBiotech Ltd.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT05919693
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 33
- From 12 Jun 2023 to the primary completion date, 26 Aug 2024
- 31 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening
- Any other condition except for DME or NVAMD or that could affect interpretation of study assessments
Other
- Be pregnant or breastfeeding
- Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening
Who the study is looking for
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age
- Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.
- DME patients must have vision loss in the study eye
- NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Caba, Argentina Coordinator of this site? Confirm its status | Caba | Argentina | Unknown status |
| Ciudad Autonoma Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| London, UK Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| London, England Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Arecibo, PR Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Abilene, TX Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Amarillo, TX Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Austin, TX Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Bakersfield, CA Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Bellaire, TX Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Colorado Springs, Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Dallas, TX Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Germantown, TN Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Hagerstown, MD Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Katy, TX Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Knoxville, TN Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Lakewood, CO Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Lemont, NV Coordinator of this site? Confirm its status | Lemont | United States | Unknown status |
| McAllen, TX Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Modesto, CA Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Mountain View, CA Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Nashville, TN Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Phoenix, AZ Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Plano, TX Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Pompano Beach Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
| Reno, NV Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Round Rock, TX Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Sacramento, CA Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| San Antonio, TX Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| The Woodlands, TX Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| West Columbia, SC Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.