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

Sponsor

Institute of Molecular and Clinical Ophthalmology Basel (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05963646

Collaborator

Boehringer Ingelheim (Industry)

Enrollment

Location

33.5

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Geographic Atrophy Visual Field Defect, Central Scotoma of Both Eyes	Diagnostic Test: Natural history study

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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 16, 2021

Actual Primary Completion Date :

Jun 23, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Change in retinal sensitivity in the junctional zone [Week 12]
Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry
Change in retinal pigment epithelium (RPE) thickness in the junctional zone [Week 12]
Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT
Change in photoreceptor thickness in the junctional zone [Week 12]
Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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 Criteria:

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