Subretinal CPCB-RPE1 implant for advanced dry AMD with geographic atrophy

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 is a Phase IIb randomized, multicenter trial testing a unilateral subretinal CPCB-RPE1 implant versus a simulated sham procedure. Twenty-four participants will be randomized 3:1 (up to 18 receiving the implant and up to 6 receiving sham) and treated at up to six surgical implantation sites with additional referral or follow-up centers as needed. Eligible eyes must have geographic atrophy involving the fovea between 4.0 mm2 and 15.0 mm2 and best-corrected visual acuity between 20/200 and 20/63. Participants must be medically suitable for pars plana vitrectomy and perioperative anesthesia and able to comply with postoperative positioning and medications.

Why it matters

Who can join: the full rules

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 15.0 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.

Where it's running

• Retina Associates of Southern California
  Huntington Beach, California, United States Recruiting
• USC - Keck
  Los Angeles, California, United States Recruiting
• University Retina
  Lemont, Illinois, United States Recruiting
• Austin Retina Associates
  Austin, Texas, United States Recruiting
• Retina Consultants of Texas
  The Woodlands, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Research
• Email: clinicaltrials@regenerativepatch.com
• Phone: 833-734-3678

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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.