Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing iPSC-derived RPE/PLGA transplantation for Dry Age-Related Macular Degeneration

Background: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots.

Official registry: https://clinicaltrials.gov/study/NCT04339764 · National Eye Institute (NEI) · enrollment listed as 20

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are iPSC-derived RPE/PLGA transplantation. The registry lists allocation as na. Background: Age-related macular degeneration is a common eye disease in people over 50.

They plan to enroll about 20 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase I/IIa Trial for Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration

Interventions: iPSC-derived RPE/PLGA transplantation

Primary outcome (registry wording): Summary of adverse events

Who it is for (from inclusion criteria)

  • Ages 55 Years to 95 Years
  • Participant Eligibility Criteria:
  • To be eligible, the following who can join must be met, where applicable
  • Participant must be 55 years of age or older
  • Any participant of childbearing potential must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to RPE transplantation
  • Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
  • Intrauterine device,
  • Barrier methods (diaphragm, condom) with spermicide, or

Public study contact (from the registry)

Ellaine M Galindez-Balut

(301) 402-4726

ellaine.galindez-balut@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)

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Phase 3: testing PDS Implant with Ranibizumab 100 mg/mL for Neovascular Age-Related Macular Degeneration

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NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche

FAQ about this NCT record

Is NCT04339764 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04339764?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04339764?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary