A PHASE IIB, RANDOMIZED, ASSESSOR-MASKED, MULTICENTER CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF SUBRETINAL IMPLANTATION OF THE CPCB-RPE1 IMPLANT IN SUBJECTS WITH ADVANCED, DRY AMD (GEOGRAPHIC ATROPHY)

Launched by REGENERATIVE PATCH TECHNOLOGIES, LLC · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with advanced dry age-related macular degeneration (AMD), specifically a condition called geographic atrophy. The trial will test a device called the CPCB-RPE1 implant, which is placed in the eye to see if it can help improve vision. In this study, 24 participants will be randomly divided into two groups: one group will receive the actual implant, while the other group will undergo a simulated procedure that does not involve the implant. This helps researchers compare the effects of the treatment.

To be eligible for the trial, participants need to be between 55 and 90 years old and have specific vision problems related to geographic atrophy in their eyes. They should also be medically fit for eye surgery and able to follow post-surgery instructions. Throughout the study, participants will have regular check-ups to monitor their health and vision. It's important to know that the trial is not yet recruiting participants, but it provides an opportunity for those who meet the criteria to potentially contribute to new treatment options for AMD.

Gender

ALL

Eligibility criteria

• Eligible participants include:
• • 1. Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
• • 2. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 10.0 mm2 of geographic atrophy involving the fovea.
• • 3. Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
• • 4. The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant.
• • 5. Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
• • 6. Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
• • 7. Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
• • 8. Participants also must be willing and able to provide written, signed informed consent for this study.
• • 9. Participants able to complete the baseline microperimetry retinal sensitivity testing.
• • 10. On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.