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Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study | Clinical Trials | Clareo Health

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Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study

NCT05963646•Institute of Molecular and Clinical Ophthalmology Basel

View on ClinicalTrials.gov

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 optical coherence tomography imaging for assessing changes in retinal sensitivity and anatomy over time.

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 structural outcome measures for monitoring GA progression. This prospective, natural-history study was performed at a tertiary referral center (University Hospital Basel, PI: Prof. Dr. med. Hendrik P.N. Scholl). The study included a baseline visit and follow-up visits at weeks 12, 24, and 48.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the study
•2. Age \>60 years
•3. 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
•4. GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in the study eye
•5. GA lesion in the study eye must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)
•6. BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m in the study eye
•7. 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).
•8. Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging in the study eye.

Exclusion Criteria

•1. 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 \[e.g., chloroquine/hydroxychloroquine maculopathy\])
•2. Receiving active treatment in any studies of investigational drugs for GA/dry AMD in the study eye
•3. Mean sensitivity difference \> 3 dB between the two microperimetry examinations in the screening visit.
•4. History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
•5. Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy in the study eye
•6. Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
•7. History of prophylactic subthreshold laser treatment for AMD in the study eye
•8. 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.
•9. RPE tear that involves the macula in either eye
•10. 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:
+3 more criteria

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Key Dates

Start Date

March 16, 2021

Primary Completion Date

June 23, 2023

Completion Date

December 31, 2023

Last Updated

February 19, 2025

Enrollment

ACTUAL participants

Conditions

Age-Related Macular DegenerationGeographic AtrophyVisual Field Defect, Central Scotoma of Both Eyes

Interventions

Natural history study

DIAGNOSTIC_TEST

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RECRUITING

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RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study

Inclusion Criteria

Exclusion Criteria

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