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Age-Related Macular DegenerationOMEGANCT05963646

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

An observational study of Age-Related Macular Degeneration and Geographic Atrophy, run by Institute of Molecular and Clinical Ophthalmology Basel at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Natural history study
How many people
30 participants
Where
1 siteSwitzerland
Study dates
16 Mar 2021to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with manifest geographic atrophy (total GA lesion size >1.2 mm2) secondary to age-related macular degeneration

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, Canton of Basel-City, CH-4031

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Natural history study
Keywords
Microperimetry, Fundus-controlled perimetry
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural history studyDiagnostic test

    Patients were monitored with a panel of visual function tests and imaging modalities. Functional tests included best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), and contrast sensitivity function evaluation (qCSF method). Imaging assessments included fundus autofluorescence, optical coherence tomography and optical coherence tomography angiography.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in retinal sensitivity in the junctional zone

    Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry

    Measured: Week 12

  2. Change in retinal pigment epithelium (RPE) thickness in the junctional zone

    Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT

    Measured: Week 12

  3. Change in photoreceptor thickness in the junctional zone

    Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start16 Mar 2021
  3. Primary completion23 Jun 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963646
Sponsor's protocol ID
OMEGA
Acronym
OMEGA
Status last verified
Feb 2025
First submitted
19 Jul 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 17239336

  • 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.

    PubMed 30300264

  • 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.

    PubMed 32789526

  • Ansari G, Scharer N, Camenzind Zuche H, Gabrani C, Anders P, Pfau K, Valmaggia P, Giani A, Esmaeelpour M, Chingning Yamaguchi T, Prunte CF, Maloca PM, Schmetterer L, Scholl HPN, Pfau M. The Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients with Geographic Atrophy (OMEGA) Study: Design and Baseline Characteristics - OMEGA Report 1. Ophthalmic Res. 2023;66(1):1392-1401. doi: 10.1159/000535375. Epub 2023 Nov 28.

    PubMed 38016431

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration and Geographic Atrophy, run by Institute of Molecular and Clinical Ophthalmology Basel at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in retinal sensitivity in the junctional zone (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963646, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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