Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorShanghai Refreshgene Technology Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RRG001

    Drug

    Administered via Subretinal injection. Dosage form: injection solution.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: RRG001 Dose1Experimental treatment 1 intervention
Group B: RRG001 Dose2Experimental treatment 1 intervention
Group C: RRG001 Dose3Experimental treatment 1 intervention
Group D: RRG001 Dose4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability

incidence of AEs and SAEs

Time frame
Week 52

Secondary outcomes

1

Efficacy after RRG001 injection

change in best-corrected visual acuity (BCVA);

Time frame
Week 52
2

Efficacy after RRG001 injection

change in central retinal thickness (CRT)

Time frame
Week 52

Other outcomes

Sponsors and contacts

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