A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

ConditionsDry Age-related Macular Degeneration Geographic Atrophy

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55-90

SponsorRegenerative Patch Technologies, LLC

About this trial

This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea.

Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups:

* The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). * The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.

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.

Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Surgical implantation of the CPCB-RPE1 implant
Device
Surgical implantation of the CPCB-RPE1 implant

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).Experimental treatment 1 intervention

Group B: Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in retinal sensitivity

Change in retinal sensitivity by microperimetry

Time frame

1 year post implantation

Secondary outcomes

Change in best corrected visual acuity

Time frame

1 year post implantation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regenerative Patch Technologies, LLC

Lead sponsor

California Institute for Regenerative Medicine (CIRM)

Collaborator

Source ClinicalTrials.gov

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