Clinical trial for Dry Age-Related Macular Degeneration
Official title Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT04339764
What this study is testing
What is iPSC-derived RPE/PLGA transplantation?
This is an investigational cell therapy being studied as a potential treatment for dry age-related macular degeneration. It is designed to replace damaged retinal pigment epithelium cells in the eye with new cells grown from the patient's own blood.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if putting lab‑grown retinal cells into the eye is safe for treating this eye disease.
- Who it's for
- Adults 55 years or older who have geographic atrophy and vision loss from dry age‑related macular degeneration.
- What's involved
- Participants will undergo many eye and medical tests, have a surgery that puts new cells into one eye, and take medicines to prevent rejection. They will have regular follow‑up visits and yearly check‑ups for up to 15 years.
- Time commitment
- The study lasts about 5½ years with at least 14 visits, plus yearly contacts for up to 15 years.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 95
You may be able to join if
- Participant must be 55 years of age or older.
- Participant must have a diagnosis of dry AMD, defined as presence (or history, as documented in available color fundus photographs) of at least one...
- Participant must understand and sign the protocol s informed consent document.
- Any participant of childbearing potential must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to...
- Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
You likely can't join if
- The study eye must have one or more regions of geographic atrophy with total area of 1 disc area or more.
- For participants in the first cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \ = CF (i.e., Snellen...
- For participants in the second cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \ = CF (i.e., Snellen...
- The compromise in visual acuity for the study eye must be judged predominantly secondary to dry AMD, in the judgment of the investigator.
- The study eye must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography and safe vitrectomy...
- Participant is actively receiving another study medication / investigational product (IP).
See the full eligibility criteria
- Participant must be 55 years of age or older.
- Participant must have a diagnosis of dry AMD, defined as presence (or history, as documented in available color fundus photographs) of at least one medium or large druse (greater than or equal to 63 micrometer diameter)...
- Participant must understand and sign the protocol s informed consent document.
- 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
- Surgical sterilization (tubal ligation).
- Participant must be medically able to comply with the study treatment (including ability to safely receive anesthesia for surgery), study testing and procedures, and follow-up visits.
- The study eye must have one or more regions of geographic atrophy with total area of 1 disc area or more.
- For participants in the first cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \ = CF (i.e., Snellen equivalent between 20/100 and CF), and the fellow eye must have a letter...
- For participants in the second cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \ = CF (i.e., Snellen equivalent between 20/80 and CF), and the fellow eye must have a letter...
- The compromise in visual acuity for the study eye must be judged predominantly secondary to dry AMD, in the judgment of the investigator.
- The study eye must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography and safe vitrectomy surgery.
- Participant is actively receiving another study medication / investigational product (IP).
- Participant has any condition that significantly increases risk of systemic corticosteroids or systemic steroid-sparing immuno-modulatory agents, such as uncontrolled diabetes mellitus (defined as HbA1C \> 7.5 at...
- Participant has diagnosis of a malignancy expected to affect two-year survival.
- Participant is pregnant, breast-feeding, or planning to become pregnant through the first 12 months of the study.
- Participant has a family history of a retinal degeneration other than AMD suspected to play a role in the ocular phenotype of the participant in the judgment of the investigator, based on disease features and mode of...
- Participant is taking, or has taken within the previous year, medication with known potential toxicity to the retina, optic nerve, or lens (such as chloroquine, hydroxychloroquine, ethambutol).
- Participant is taking any form of systemic anticoagulation which cannot be stopped for an indefinite period of time without significant risk.
- The study eye has macular, subretinal or choroidal neovascularization, as assessed by FA and OCT; or any history of such neovascularization (as assessed by past available records or images).
- The study eye has serous or hemorrhagic pigment epithelial detachment, as assessed by FA and OCT, that is clinically significant in the judgment of the investigator.
- The study eye has a history of photodynamic therapy (PDT) or macular thermal laser photocoagulation, or history of intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents or corticosteroids...
- The study eye has an axial length \> 26.0 mm.
- The study eye has had surgery in the previous 12 weeks, or laser capsulotomy in the previous four weeks.
- The study eye has chronic glaucoma; OR significant ocular hypertension, defined as documented intraocular pressure of \>= 26 mmHg on at least two occasions in the absence of self-limited acute glaucoma
- The study eye has a condition materially increasing the risks of surgery or potentially affecting visual function over the next two years in the judgment of the investigator, such as chronic uveitis, diabetic...
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.