Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
Recruiting
Phase 3
Interventional Study
Neovascular Age-Related Macular Degeneration (nAMD)
Wet AMD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 388 (estimated)
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd · Industry
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About This Trial
This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Willing and able to provide written, signed informed consent for this study;
2. Age ≥50 and ≤80 years old;
3. Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;
4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;
5. Demonstrate…
Contacts
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