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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.
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

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Caba, Argentina
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CabaArgentinaUnknown status
Ciudad Autonoma Buenos Aires
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
London, UK
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LondonUnited KingdomUnknown status
London, England
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LondonUnited KingdomUnknown status
Arecibo, PR
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AreciboPuerto RicoUnknown status
Abilene, TX
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AbileneUnited StatesUnknown status
Amarillo, TX
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AmarilloUnited StatesUnknown status
Austin, TX
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AustinUnited StatesUnknown status
Bakersfield, CA
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BakersfieldUnited StatesUnknown status
Bellaire, TX
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BellaireUnited StatesUnknown status
Colorado Springs, Colorado
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Colorado SpringsUnited StatesUnknown status
Dallas, TX
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DallasUnited StatesUnknown status
Germantown, TN
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GermantownUnited StatesUnknown status
Hagerstown, MD
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HagerstownUnited StatesUnknown status
Katy, TX
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KatyUnited StatesUnknown status
Knoxville, TN
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KnoxvilleUnited StatesUnknown status
Lakewood, CO
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LakewoodUnited StatesUnknown status
Lemont, NV
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LemontUnited StatesUnknown status
McAllen, TX
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McAllenUnited StatesUnknown status
Modesto, CA
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ModestoUnited StatesUnknown status
Mountain View, CA
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Mountain ViewUnited StatesUnknown status
Nashville, TN
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NashvilleUnited StatesUnknown status
Phoenix, AZ
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PhoenixUnited StatesUnknown status
Plano, TX
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PlanoUnited StatesUnknown status
Pompano Beach
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Pompano BeachUnited StatesUnknown status
Reno, NV
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RenoUnited StatesUnknown status
Round Rock, TX
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Round RockUnited StatesUnknown status
Sacramento, CA
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SacramentoUnited StatesUnknown status
San Antonio, TX
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San AntonioUnited StatesUnknown status
The Woodlands, TX
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The WoodlandsUnited StatesUnknown status
West Columbia, SC
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West ColumbiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.