Status:
COMPLETED
Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study
Lead Sponsor:
Institute of Molecular and Clinical Ophthalmology Basel
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Age-Related Macular Degeneration
Geographic Atrophy
Eligibility:
All Genders
60+ years
Brief Summary
This study is a biomarker evaluation study in patients with geographic atrophy secondary to age-related macular degeneration (AMD). The study evaluates microperimetry (fundus-controlled perimetry) and...
Detailed Description
The optical coherence tomography (OCT) and microperimetry biomarker evaluation in patients with GA (OMEGA) study aims to systematically compare a panel of established and novel visual function and str...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study
- Age \>60 years
- Ability (including a sufficient general health status according to investigators judgement) and willingness to undertake all scheduled visits and assessments including predefined methodology and standards utilizing microperimetry
- GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye
- GA lesion in the study eye must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
- BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye
- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV in the study eye. The total GA lesion size \>1.2 mm2 (approximately \>0.5 disc area \[DA\]) and \<17.78 mm2 (approximately \<7 DA) and must reside completely within the FAF imaging field (Field 2, i.e., 30 degree image centered on the fovea). If GA is multifocal, at least 1 focal lesion must be \>1.2 mm2 (approximately \>0.5 DA).
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye.
Exclusion
- GA in either eye due to causes other than AMD (for example, monogenetic macular dystrophies \[e.g., Stargardt disease, cone rod dystrophy\] or toxic maculopathies \[e.g., chloroquine/hydroxychloroquine maculopathy\])
- Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
- Mean sensitivity difference \> 3 dB between the two microperimetry examinations in the screening visit.
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
- Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- History of prophylactic subthreshold laser treatment for AMD in the study eye
- Previous intravitreal drug delivery in the study eye (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
- RPE tear that involves the macula in either eye
- Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following:
- Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
- If allowed to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of BCVA during the study period
- Previous violation of the posterior capsule in the study eye unless it occurred as a result of Yttrium Aluminum Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
Key Trial Info
Start Date :
March 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05963646
Start Date
March 16 2021
End Date
December 31 2023
Last Update
February 19 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, CH-4031