Gene therapy for neovascular age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a single subretinal injection of RRG001 in patients with neovascular age-related macular degeneration (nAMD). It employs a multicenter, single-arm, open-label design, consisting of a Phase I dose-escalation study followed by a Phase IIa dose-expansion study. The Phase I component will enroll 3-6 subjects per dose group, while the Phase IIa will expand to 12 subjects per group based on safety assessments. The goal is to determine the optimal dosing and assess the treatment's effectiveness in improving vision.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects that are willing and able to follow study procedures.
* Patinets ≥50 years old.
* Clinically diagnosed with CNV secondary to nAMD.
* BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20/800\~20/40), as well as that of the other eye ≥19 letters(Snellen 20/400).
* Responding to anti-VEGF

Exclusion Criteria:

* Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.
* CNV or macular edema in the study eye secondary to any causes other than AMD.
* Uncontrolled glaucoma.
* Uncontrolled hypertension despite medication.
* Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.

Where it's running

• Tianjin Medical University Eye Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaorong Li, Master
• Email: xiaorong.li@163.com
• Phone: 8602223346434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.