NCT06141460 Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
| NCT ID | NCT06141460 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Refreshgene Technology Co., Ltd. |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2026-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2023-12-12 with a primary completion date of 2026-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase I/IIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06141460 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06141460 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06141460 currently recruiting?
Yes, NCT06141460 is actively recruiting participants. Contact the research team at xiaorong.li@163.com for enrollment information.
Where is the NCT06141460 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06141460 clinical trial?
NCT06141460 is sponsored by Shanghai Refreshgene Technology Co., Ltd.. The trial plans to enroll 48 participants.