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

Korábbi kezelés

• Receiving active treatment in any studies of investigational drugs for GA/dry 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
• 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.
• 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

Más betegség

• 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])
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
• History of prophylactic subthreshold laser treatment for AMD in the study eye

Egyéb

• Mean sensitivity difference > 3 dB between the two microperimetry examinations in the screening visit.
• RPE tear that involves the macula in either eye

• 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.