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

NCT05963646 | Completed

• 1 other identifier: OMEGA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration; Geographic Atrophy; Visual Field Defect, Central Scotoma of Both Eyes

Keywords

Microperimetry; Fundus-controlled perimetry

Outcome Measures

Primary Outcomes (3)

• 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

  Week 12

• 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

  Week 12

• 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

  Week 12

Interventions

Natural history study DIAGNOSTIC_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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Molecular and Clinical Ophthalmology Basel: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, CH-4031, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 17239336 BACKGROUND

• 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.

  PMID: 30300264 BACKGROUND

• 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.

  PMID: 32789526 BACKGROUND

• 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.

  PMID: 38016431 RESULT

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: March 16, 2021
• Primary Completion: June 23, 2023
• Study Completion: December 31, 2023
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CH (1)