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New treatment option 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?
iPSC-derived RPE/PLGA transplantation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dry age-related macular degeneration.
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
- 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.
- 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 Eligibility Criteria: To be eligible, the following must be met, where applicable.
- 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...
You likely can't join if
- listed below. The fellow eye must also meet the relevant eligibility criteria listed below. Study Eye Inclusion Criteria:
- The study eye must have one or more regions of geographic atrophy with total area of 1 disc area or more. A region of geographic atrophy is defined...
- 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...
See the full eligibility criteria
Who can join
- Participant Eligibility Criteria: To be eligible, the following must be met, where applicable.
- 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.
- Any participant of childbearing potential and any participant able to father children who has a partner of childbearing potential must have (or have a partner who has) had a hysterectomy or vasectomy, be completely...
- 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. Study Eye/Fellow Eye Eligibility...
What rules you out
- listed below. The fellow eye must also meet the relevant eligibility criteria listed below. Study Eye Inclusion Criteria:
- The study eye must have one or more regions of geographic atrophy with total area of 1 disc area or more. A region of geographic atrophy is defined as an area of uniform hypofluorescence on fundus autofluorescence (FAF)...
- 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.
- The study eye must be either pseudophakic or aphakic. EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present:
- 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 determination of significant risk to the participant must be at the...
- Participant is unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research. Study Eye Exclusion Criteria:
- 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 \> 25.0 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; OR history of...
- 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's taking place
- Baltimore, Maryland, United States
- 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 - 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?
Study sites include Baltimore, Maryland, United States; Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.