Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial

• Published in: Graefe's archive for clinical and experimental ophthalmology Vol. 260; no. 1; pp. 47 - 54
• Main Authors: Yu, Hannah J., Fuller, Dwain, Anand, Rajiv, Fuller, Timothy, Munoz, Jose, Moore, Chelsey, Kim, Ryan S., Schefler, Amy C.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2022; Springer Nature B.V
• Subjects: Acuity; Angiogenesis Inhibitors - therapeutic use; Diabetes mellitus; Diabetic retinopathy; Edema; Exudates; Eye; Hemorrhage; Humans; Intravitreal Injections; Laser Coagulation; Macular Edema - diagnosis; Macular Edema - drug therapy; Macular Edema - etiology; Medicine; Medicine & Public Health; Monoclonal antibodies; Ophthalmology; Prospective Studies; Radiation; Ranibizumab - therapeutic use; Retina; Retinal Disorders; Retinopathy; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Visual Acuity; Targeted retinal photocoagulation; Uveal melanoma; Brachytherapy; Macular edema; Anti-vascular endothelial growth factor; Radiation retinopathy
• ISSN: 0721-832X; 1435-702X; 1435-702X
• DOI: 10.1007/s00417-021-05281-2

Purpose To assess the efficacy of a treat-and-extend strategy with intravitreal ranibizumab for radiation-related macular edema. Methods Forty eyes with radiation-induced macular edema and decreased visual acuity were enrolled in the phase IIb, prospective clinical trial and randomized into 3 cohorts: (A) monthly ranibizumab, (B) monthly ranibizumab with targeted retinal photocoagulation (TRP), or (C) as-needed ranibizumab and TRP. In year 2, all subjects entered a treat-and-extend protocol for ranibizumab. The primary outcome measure was mean change in early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) from baseline. Results Through year 1, the mean change in ETDRS BCVA was significantly different between the three cohorts (p < 0.001); cohort A saw the largest gain with + 4.0 letters. Significant anatomic improvements were also seen in all cohorts. Comparatively, through year 2, cohorts A, B, and C had a mean change in ETDRS BCVA of − 1.9, − 3.9, and + 1.3 letters, respectively; additionally, no significant differences were found in absolute ETDRS BCVA across time (ANOVA, p = 0.123). Overall, 90% of eyes maintained VA 20/200 or better and 33.3% of subjects gained at least one line of vision. There were no significant differences in mean central macular thickness for any cohort compared to baseline (p = 0.09). The presence of retinal hemorrhage and intraretinal exudates stayed consistent from year 1 to year 2 for all cohorts. Conclusions Among eyes with radiation-related macular edema, a treat-and-extend regimen with ranibizumab may not result in as many visual and anatomic improvements as monthly injections. However, treat-and-extend still may prevent serious visual complications compared to historical controls. Trial registration ClinicalTrials.gov Identifier: NCT02222610