NCT07817615Not yet recruitingPhase 1
A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion
A Phase I, Open-label, Dose-escalation, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intravitreal Injection of GenSci148 in Participants With Neovascular Age-related Macular Degeneration (nAMD) and Multiple Intravitreal Injections of GenSci148 in Participants With nAMD, Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This is a Phase I, multicenter, open-label, dose-escalation study conducted in two parts to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GenSci148 administered via intravitreal (IVT) injection in participants with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Part 1 evaluates single ascending doses in nAMD participants. Part 2 evaluates multiple doses in nAMD, DME, and RVO participants. The study also assesses immunogenicity and explores preliminary efficacy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT07817615
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From Sept 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- 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.
Prior treatment
- Prior or current contraindicated ophthalmic treatments in study or fellow eye per protocol.
Other illness
- Anterior segment neovascularization or vitreous hemorrhage in the study eye.
Other
- Refractive error \> ±8.0 diopters in the study eye.
Who the study is looking for
- Able to understand the study and provide written informed consent prior to any study-related procedures.
- Willing and able to comply with scheduled visits, treatment plan, and study procedures.
- Best corrected visual acuity (BCVA) of 24 to 78 letters (inclusive) in the study eye, and BCVA ≥ 24 letters in the fellow eye.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.