Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04339764 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 250 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Interventions: iPSC-derived RPE/PLGA transplantation (Drug) to iPSC-derived RPE/PLGA transplantation (Drug)
    • Eligibility criteria expanded, about 26 words
  4. 3 versions Re-verified since Jun 18, 2026, no change to tracked fieldsv245-v247
  5. Eligibility criteria expanded, about 47 wordsv244
Show 43 earlier versionsHide 43 earlier versions
  1. 7 versions Re-verified since Jun 28, 2025, no change to tracked fieldsv237-v243
  2. Eligibility criteria revisedv236
  3. 7 versions Re-verified since Apr 25, 2024, no change to tracked fieldsv229-v235
  4. Eligibility criteria expanded, about 81 wordsv228
  5. 2 versions Re-verified since Feb 26, 2024, no change to tracked fieldsv226-v227
  6. Site details revised at 1 of 2 sitesv225
  7. 3 versions Re-verified since Nov 22, 2023, no change to tracked fieldsv222-v224
  8. Study sites: 1 to 2
    • Eligibility criteria expanded, about 45 words
    v221
  9. Eligibility criteria expanded, about 44 words
    • Study description expanded, about 4 words
    v220
  10. 4 versions Re-verified since Feb 25, 2023, no change to tracked fieldsv216-v219
  11. Study Status, Study Descriptionv215
  12. Interventions: iPSC-derived RPE/PGLA transplantation (Drug) to iPSC-derived RPE/PLGA transplantation (Drug)v214
  13. Re-verified, no change to tracked fieldsv213
  14. Interventions: iPSC-derived RPE/PGLA transplantation (Biological) to iPSC-derived RPE/PGLA transplantation (Drug)v212
  15. Interventions: iPSC-derived RPE/PGLA transplantation (Drug) to iPSC-derived RPE/PGLA transplantation (Biological)v211
  16. 2 versions Re-verified since Dec 14, 2022, no change to tracked fieldsv209-v210
  17. Interventions: iPSC-derived RPE/PLGA transplantation (Drug) to iPSC-derived RPE/PGLA transplantation (Drug)v208
  18. 7 versions Re-verified since Jun 24, 2022, no change to tracked fieldsv201-v207
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease. Objective: To test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration. Eligibility: People ages 55 and older who have geographic atrophy with loss of vision. People who have had "wet" macular degeneration in study eye are NOT eligible. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Eye exam * Eye photos * Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels. * Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights. * Tuberculosis test * Chest X-ray * Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity. Participants will have at least 14 study visits over 5 and a half years. They will repeat screening tests. Participants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will receive immunosuppressive medications to avoid transplant rejection. Participants will be contacted yearly for up to 15 years....
Trial Details
NCT Number NCT04339764
Lead Sponsor National Eye Institute (NEI)
Conditions
(from sponsor)		 Dry Age-Related Macular Degeneration, Geographic Atrophy
Related terms Geographic Atrophy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov