Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). | Experimental | Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects). |
|
| Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) | Sham Comparator | Control group receiving a simulated "sham" implantation procedure (up to 6 subjects) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical implantation of the CPCB-RPE1 implant | Device | Surgical implantation of the CPCB-RPE1 implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal sensitivity | Change in retinal sensitivity by microperimetry | 1 year post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected visual acuity | Change in best corrected visual acuity | 1 year post implantation |
Not provided
Eligible participants include:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Contact | 833-734-3678 | clinicaltrials@regenerativepatch.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Recruiting | Beverly Hills | California | 90211 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial
Not provided
Not provided
Not provided
| Retina Associates of Southern California | Recruiting | Huntington Beach | California | 92647 | United States |
|
| USC - Keck | Recruiting | Los Angeles | California | 90033 | United States |
|
| University Retina | Recruiting | Lemont | Illinois | 60439 | United States |
|
| Retina Consultants of Texas | Recruiting | The Woodlands | Texas | 77384 | United States |
|
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided