Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degenā¦ (NCT02286089) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
United States, Israel24 participantsStarted 2015-04-01
Plain-language summary
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 50 and older;
* Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes;
* Funduscopic findings of dry age-related macular degeneration (AMD) with progressive geographic atrophy in the macula;
* Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing;
* Vision in the non-operated eye must be better than or equal to that in the operated eye;
* Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow up period (based on medical records);
* Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care;
* Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance;
* Negative for tuberculosis (TB) (cohort 4), human immunodeficiency virus (HIV), hepatitis B (HBC), and hepatitis C virus (HCV), negative for cytomegalovirus (CMV) Immunoglobulin (IgM) and Epstein-Barr Virus (EBV) IgM or asymptomatic in the opinion of the investigator (cohort 4);
* No history of malignancy (other than a non-melanoma skin cancer). For cancers in remission for more then 5 years enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment;
* Willing to defer all future blood and tissue donation;
* Able to understand study procedures and willing to sign informed consent.
Exclusion Criteria:
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What they're measuring
1
Percentage of Participants With Treatment Emergent Adverse Events
Timeframe: From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years)
2
Change From Baseline in Intraocular Pressure (IOP)