Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06351657
Eligibility Criteria:
Inclusion Criteria:
* Age: 55-99 years old
* Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
* If both eyes are eligible, both eyes will be included in the cohort study.
* Clear optical media and adequate pupillary dilation for imaging and functional testin
Exclusion Criteria:
* Any surgical treatment of the eye within 3 months prior to baseline in the study eye
* History of anti-VEGF treatment in the study eye before baseline
* History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
* History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio \> 0.9
* Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
* Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery and YAG capsulotomy) during the study period
* Presence of corneal decompensation, haze or scarring with an impact on BCVA
* Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters.
* Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen)
* Presence of active macular neovascularization at baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
99 Years
Study:
NCT06351657
Study Brief:
Protocol Section:
NCT06351657