Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic … (NCT05963646) | Clinical Trial Compass
CompletedNot Applicable
Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study
Switzerland30 participantsStarted 2021-03-16
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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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 \[e.g., chloroquine/hydroxychloroquine maculopathy\])
What they're measuring
1
Change in retinal sensitivity in the junctional zone
Timeframe: Week 12
2
Change in retinal pigment epithelium (RPE) thickness in the junctional zone
Timeframe: Week 12
3
Change in photoreceptor thickness in the junctional zone
Timeframe: Week 12
Trial details
NCT IDNCT05963646
SponsorInstitute of Molecular and Clinical Ophthalmology Basel
✕. 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.