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Tests treatment safety and results for Retinal Disease
Official title Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
ClinicalTrials.gov ID: NCT06394232
What this study is testing
What is Eyecyte-RPE™?
Eyecyte-RPE™ is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for retinal disease.
Also referred to as Subretinal Injection, Oral Tacrolimus.
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 goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD). The main questions it aims to answer are: Safety and tolerability of the novel stem cell formulation Potential efficacy of the novel stem cell formulation Participants will receive a single subretinal injection in their study eye and followed up for safety.
- 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 50 to 100
You may be able to join if
- Men and women ≥ 50 years of age at Screening.
- Diagnosis of Geographic Atrophy secondary to d-AMD
- Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.
- Phase 1 ≤ 20/200 and
- Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.
You likely can't join if
- Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.
- Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in...
- Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid...
- Axial myopia greater than -6 diopters or axial length more than 26 mm.
- Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous...
- Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.
See the full eligibility criteria
Who can join
- Men and women ≥ 50 years of age at Screening.
- Diagnosis of Geographic Atrophy secondary to d-AMD
- Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.
- Phase 1 ≤ 20/200 and
- Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.
- Vision in the unoperated eye must be better or equal to vision in the study eye.
- Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
- Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.
- Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.
- Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand, and willing to sign the informed consent form (ICF)
- Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.
- Negative for HIV, HbsAg, HCV, TB
- The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
- Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas [DA] respectively)
- The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
- At least one of the lesions has to be sub-foveal.
What rules you out
- Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.
- Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in either eye.
- Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, uveitis, punctate inner choroidopathy, or...
- Axial myopia greater than -6 diopters or axial length more than 26 mm.
- Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous vitreoretinal surgery, retinal dystrophies, non-retinal conditions, visually...
- Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.
- Have a history or evidence of vitreous hemorrhage in the study eye.
- Have a history or clinical evidence of severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion or any other vascular disease affecting the retina in the study eye.
- Have had a prior pars plana vitrectomy in the study eye.
- Have a history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Have history of a macular hole in the study eye.
- Have had any other ocular surgery (except cataract) within 2 months or Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks.
- Have had a prior trabeculectomy or other filtration surgery in the study eye.
- History of any form of glaucoma in the study eye.
- Patients with ocular pathology, particularly that of retina (other than AMD).
- Have active intraocular inflammation or a history or evidence of uveitis in either eye.
- Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the 2 weeks prior to Visit 1, Screening in either eye.
- Have a history of scleromalacia in either eye.
- Have had previous therapeutic radiation in the study eye.
- Have a history of corneal transplant or corneal dystrophy.
- Have any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular...
- Have a history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an...
- Have participated as a subject in any clinical study within 6 months prior to Day 0, Baseline.
- Have a known serious allergy to fluorescein sodium for injection in angiography, Povidone Iodine or any of the other medications required for anesthesia or the subretinal injection procedure.
- Be a female who is pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study at Screening and Baseline.
- Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery.
- Have any systemic condition that would qualify the subject as being immunocompromised (e.g., severely uncontrolled diabetes, cancer).
- Patients with Optic Atrophy
The study team makes the final eligibility decision.
Where it's taking place
- Jālna, Maharashtra, India
- Delhi, New Delhi, India
- Hyderabad, Telangana, India
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, 50 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jālna, Maharashtra, India; Delhi, New Delhi, India; Hyderabad, Telangana, India. 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.