First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
Public ClinicalTrials.gov record NCT04246866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities (DLTs). Each subject will be followed for safety, pharmacokinetic (PK), clinical, and biomarker evaluations. Three escalating dose cohorts are planned.
Study identification
- NCT ID
- NCT04246866
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 19, 2019 (Actual)
- Primary completion
- Oct 21, 2020 (Actual)
- Completion
- Oct 21, 2020 (Actual)
- Last update posted
- Feb 11, 2021
2019 – 2020
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | — |
| Retinal Consultants of Arizona | Phoenix | Arizona | 85053 | — |
| California Retina Consultants | Bakersfield | California | 93309 | — |
| Retina Vitreous Associates | Beverly Hills | California | 90211 | — |
| California Retina Consultants | Oxnard | California | 93036 | — |
| California Retina Consultants | Santa Barbara | California | 93103 | — |
| California Retina Consultants | Santa Maria | California | 93454 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | — |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| Western Carolina Retinal Associates | Asheville | North Carolina | 28803 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04246866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2021 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04246866 live on ClinicalTrials.gov.