Treatment for wet age-related macular degeneration using EXG102-031

An Open-label, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Efficacy of EXG102-031 Intraocular Injection in Participants With Neovascular Age-related Macular Degeneration（wAMD）

This study is testing a new eye injection to see if it can help people over 50 with wet age-related macular degeneration by blocking harmful blood vessel growth and improving their vision.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Hangzhou Jiayin Biotech Ltd (Industry-sponsored)
• Drugs / interventions: ranibizumab
• Locations: 8 sites (Peking, Beijing and 7 other locations)
• Trial ID: NCT06183814 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of EXG102-031, an intraocular injection designed to block abnormal blood vessel growth in patients with wet age-related macular degeneration (wAMD). The study is conducted in two phases, focusing on participants aged 50 and older who have an active lesion in the study eye. By assessing the drug's tolerability and potential to improve vision, the trial aims to provide a new treatment option for this condition. Participants will be monitored for their response to the treatment over time.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of active wAMD and specific visual acuity scores.

Not a fit: Patients with other ocular diseases affecting vision or severe retinal damage in the study eye may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from wAMD.

How similar studies have performed: Previous studies on similar approaches targeting abnormal blood vessel growth in wAMD have shown promise, indicating potential for success with this novel treatment.

Eligibility criteria

Inclusion Criteria:

1. Male or female, age ≥ 50 years of age;
2. Diagnosis of wAMD and current active lesion in the study eye at Screening;
3. An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
4. Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
5. The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.

Exclusion Criteria:

1. Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
2. Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
3. The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
4. Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
5. Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
6. Prior receipt of any ocular or systemic gene therapy agent.

Where this trial is running

Peking, Beijing and 7 other locations

• Beijing Hospital — Peking, Beijing, China (Not_yet_recruiting)
• Beijing Tongren Hospital,Cmu — Peking, Beijing, China (Not_yet_recruiting)
• Peking University People'S Hospital — Peking, Beijing, China (Recruiting)
• The Southwest Hospital of Amu — Chongqing, Chongqing, China (Not_yet_recruiting)
• Central theater General Hospital — Wuhai, Hubei, China (Recruiting)
• Jiangsu Provinve Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Eye Hospital,WMU — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Mingwei Zhao, PhD — Peking University People's Hospital
• Study coordinator: Sara Yang

Conditions Neovascular Age-related Macular Degeneration; Wet Age-related Macular Degeneration