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Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration
- Source :
- Ophthalmology. 127:1360-1370
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Purpose To identify baseline risk factors for macular atrophy (MA) development in HARBOR via a longitudinal assessment of monthly spectral-domain (SD)-OCT scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP) and fluorescein angiography (FA). Design Retrospective, post hoc analysis of SD-OCT images from HARBOR ( ClinicalTrials.gov identifier, NCT00891735 ), a phase 3, multicenter, prospective, randomized, double-blind, active treatment–controlled clinical trial. Participants Patients (N = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273). Methods Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined monthly from baseline to month 24 by masked reading center–trained graders. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, loss of retinal pigment epithelium, and loss of outer retinal layers. Multivariable proportional hazards regression was performed for time to atrophy development. Main Outcome Measures Risk factors for MA as determined by time to MA development over 24 months of treatment. Results Baseline risk factors for MA were confirmed from prior analyses that used CFP and FA data: absence of subretinal fluid, presence of intraretinal cysts, presence of Type 3 neovascularization, and presence of atrophy in the fellow eye. This analysis of SD-OCT data identified new baseline risk factors for MA: higher central drusen volume, lower choroidal thickness, presence of nascent atrophy, presence of reticular pseudodrusen, and increased central foveal thickness. Ranibizumab treatment regimen and dose level were not found to be risk factors for MA development. Conclusions In this analysis of a major nAMD trial using CAM atrophy criteria, new baseline risk factors for MA development were identified using an SD-OCT dataset. Risk factors for MA development identified by prior analyses were confirmed. Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.
- Subjects :
- Vascular Endothelial Growth Factor A
medicine.medical_specialty
genetic structures
Fundus Oculi
Visual Acuity
Angiogenesis Inhibitors
Retinal Pigment Epithelium
Drusen
Atrophy
Double-Blind Method
Risk Factors
Pro re nata
Ranibizumab
Ophthalmology
medicine
Macula Lutea
Prospective Studies
Fluorescein Angiography
Risk factor
medicine.diagnostic_test
business.industry
Macular degeneration
Prognosis
medicine.disease
Fluorescein angiography
eye diseases
Choroidal neovascularization
Disease Progression
Wet Macular Degeneration
sense organs
medicine.symptom
business
Tomography, Optical Coherence
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 01616420
- Volume :
- 127
- Database :
- OpenAIRE
- Journal :
- Ophthalmology
- Accession number :
- edsair.doi.dedup.....fda28ca040b2c1702bdc28177a155cf9