Longitudinal Panretinal Leakage and Ischemic Indices in Retinal Vascular Disease after Aflibercept Therapy: The PERMEATE Study.

Abstract

PURPOSE:

To characterize the longitudinal panretinal retinal vascular dynamics in diabetic macular edema (DME) and retinal vein occlusion (RVO) over a 12-month period while being treated with intravitreal aflibercept injections (IAIs).

DESIGN:

Prospective open-label study (clinicaltrials.gov identifier, NCT02503540).

PARTICIPANTS:

Thirty-one treatment-naive eyes with foveal-involving retinal edema secondary to DME and RVO.

METHODS:

Participants received 2 mg IAI every 4 weeks for the first 6 months, followed by 2 mg every 8 weeks. Ultra-widefield fluorescein angiography (UWFA; California Optos [Optos, Dunfermline, United Kingdom]) and spectral-domain OCT (Cirrus; Zeiss, Oberkochen, Germany) scans were obtained and analyzed using a novel quantitative assessment platform. Visual acuity, central subfield thickness, and adverse events also were collected.

MAIN OUTCOME MEASURES:

The primary end point was the mean change in panretinal leakage index at month 12 from baseline as measured by UWFA.

RESULTS:

Mean age was 67.1 years. At month 12, visual acuity significantly improved by a mean of 18.4±21.4 letters (P < 0.0001), and central subfield thickness also improved significantly, with a mean reduction of 301.3±250.3 μm (P < 0.0001). Mean panretinal leakage index improved significantly, decreasing from 3.4% at baseline to 0.5% at month 6 (P <0.0001) and 0.4% at month 12 (P < 0.0001). Panretinal ischemic index did not demonstrate any significant change but showed a nonsignificant increase from 5.5% at baseline to 6.1% at month 6 (P = 0.315) and 8.7% at month 12 (P = 0.193). Eyes with DME showed a decrease in leakage index from 3.5±2.7% at baseline to 1.6±0.8% at month 12 (P = 0.018) and overall stability in ischemic index from 5.0±4.1% at baseline to 4.7±3.5% at month 12 (P = 0.689). Participants with RVO showed a decrease in leakage index from 3.3±1.1% at baseline to 0.02±0.03% at 12 months (P < 0.0001) and a nonsignificant increase in ischemic index from 5.9±4.5% at baseline to 12.6±9.8% at month 12 (P = 0.172).

CONCLUSIONS:

Intravitreal aflibercept injections resulted in a dramatic reduction in panretinal leakage index. Panretinal ischemic index did not improve and trended toward worsening.

• Authors: Natalia Figueiredo, Sunil K Srivastava, Rishi P Singh, Amy Babiuch, Sumit Sharma, Aleksandra Rachitskaya, Katherine Talcott, Jamie Reese, Ming Hu, Justis P Ehlers
• Journal: Ophthalmology. Retina (Ophthalmol Retina) Vol. 4 Issue 2 Pg. 154-163 (02 2020) ISSN: 2468-6530 [Electronic] United States
• PMID: 31757691 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Recombinant Fusion Proteins
• Vascular Endothelial Growth Factor A
• aflibercept
• Receptors, Vascular Endothelial Growth Factor

Topics

• Aged
• Angiogenesis Inhibitors (administration & dosage)
• Diabetic Retinopathy (complications, diagnosis, drug therapy)
• Female
• Fluorescein Angiography (methods)
• Follow-Up Studies
• Fundus Oculi
• Humans
• Intravitreal Injections
• Macula Lutea (pathology)
• Macular Edema (diagnosis, drug therapy, etiology)
• Male
• Prospective Studies
• Receptors, Vascular Endothelial Growth Factor (administration & dosage)
• Recombinant Fusion Proteins (administration & dosage)
• Retinal Vein Occlusion (complications, diagnosis, drug therapy)
• Retinal Vessels (pathology)
• Tomography, Optical Coherence (methods)
• Treatment Outcome
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity