Neovascular Age-related Macular Degeneration (nAMD)Phase 1GenSci148-101NCT07817615
A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion
A Phase 1 study testing GenSci148 Injection in people with Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)
- What is being tested?
- GenSci148 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Oct 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior or current contraindicated ophthalmic treatments in study or fellow eye per protocol.
- Refractive error > ±8.0 diopters in the study eye.
- Anterior segment neovascularization or vitreous hemorrhage in the study eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xiaodong Sun, +86 13386259752, xdsun@sjtu.edu.cn
About this study
Official title: 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)
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.
Read the detailed description
This is a Phase I, multicenter, open-label, dose-escalation study conducted in 2 parts to evaluate the safety, tolerability, PK and PD profiles, and immunogenicity, as well as the preliminary efficacy of intravitreal injection of GenSci148 in participants with nAMD, DME and RVO.
Part 1 (Single Ascending Dose, SAD): Conducted in participants with nAMD. Four dose levels (1 mg/eye, 3 mg/eye, 7 mg/eye, and 10 mg/eye) are planned, administered via a single IVT injection. Dose escalation is determined by the Safety Review Committee (SRC) based on safety, tolerability, PK, PD, and other available data.
Part 2 (Multiple Ascending Dose, MAD): Conducted in participants with nAMD, DME, and RVO. Three dose levels (low, medium, and high) are planned. Participants will receive multiple IVT injections according to the study schedule. Disease activity assessment will be performed during follow-up, and participants meeting retreatment criteria may receive additional doses of GenSci148.
Safety assessments include adverse events, physical examinations, laboratory tests, vital signs, ECG, and ophthalmic examinations (BCVA, IOP, slit-lamp examination, , etc.). PK/PD and immunogenicity samples are collected at predefined time points.
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)
- Being tested
- GenSci148 Injection
- Keywords
- GenSci148, Diabetic Macular Edema, DME, Retinal Vein Occlusion, RVO, Intravitreal injection, Anti-VEGF, Angiopoietin-2, Neovascular Age-related Macular Degeneration, nAMD
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci148 InjectionDrug
GenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.
| Study group | Role | What they receive |
|---|---|---|
| GenSci148 Intravitreal Injection | Experimental | Participants receive intravitreal injections of GenSci148 at escalating dose levels. Part 1: single ascending dose (1 mg, 3 mg, 7 mg, 10 mg per eye). Part 2: multiple ascending doses in nAMD, DME, and RVO participants. Receives: Drug: GenSci148 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
TEAEs include ocular and systemic adverse events, graded by severity and relationship to study drug. Safety assessments include physical examination, vital signs, laboratory tests, ECG, and ophthalmic examinations.
Measured: 43 days(Part 1) and 40 weeks (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label, dose-escalation study. Part 1 (SAD) evaluates 4 dose levels of single IVT injection of GenSci148 in nAMD participants. Part 2 (MAD) evaluates 3 dose levels of multiple IVT injections in nAMD, DME, and RVO participants. Dose escalation is determined by SRC based on safety and tolerability.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817615
- Sponsor's protocol ID
- GenSci148-101
- Acronym
- GenSci148-101
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No