- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05963646
Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study (OMEGA)
July 19, 2023 updated by: Institute of Molecular and Clinical Ophthalmology Basel
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, CH-4031
- University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients with manifest geographic atrophy (total GA lesion size >1.2 mm2) secondary to age-related macular degeneration
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in retinal sensitivity in the junctional zone
Time Frame: 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
|
Week 12
|
Change in retinal pigment epithelium (RPE) thickness in the junctional zone
Time Frame: Week 12
|
Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT
|
Week 12
|
Change in photoreceptor thickness in the junctional zone
Time Frame: Week 12
|
Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22.
- Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.
- Pfau M, von der Emde L, de Sisternes L, Hallak JA, Leng T, Schmitz-Valckenberg S, Holz FG, Fleckenstein M, Rubin DL. Progression of Photoreceptor Degeneration in Geographic Atrophy Secondary to Age-related Macular Degeneration. JAMA Ophthalmol. 2020 Oct 1;138(10):1026-1034. doi: 10.1001/jamaophthalmol.2020.2914.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2021
Primary Completion (Actual)
June 23, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
July 19, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMEGA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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