TY - JOUR
T1 - Two-year results for ranibizumab for radiation retinopathy (RRR)
T2 - a randomized, prospective trial
AU - the RRR Study Group
AU - Yu, Hannah J.
AU - Fuller, Dwain
AU - Anand, Rajiv
AU - Fuller, Timothy
AU - Munoz, Jose
AU - Moore, Chelsey
AU - Kim, Ryan S.
AU - Schefler, Amy C.
AU - Bretana, Maria E.
AU - Diugnan, Karen
N1 - Funding Information:
The authors would also like to acknowledge Guangming Lang for providing significant statistical analyses of the data presented in this manuscript. He has been financially compensated for his contributions.
Funding Information:
This work was supported by Genentech, Inc (San Francisco, CA).
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - Anti-vascular endothelial growth factor
KW - Brachytherapy
KW - Macular edema
KW - Radiation retinopathy
KW - Targeted retinal photocoagulation
KW - Uveal melanoma
KW - Vascular Endothelial Growth Factor A
KW - Prospective Studies
KW - Intravitreal Injections
KW - Tomography, Optical Coherence
KW - Humans
KW - Macular Edema/diagnosis
KW - Treatment Outcome
KW - Laser Coagulation
KW - Visual Acuity
KW - Angiogenesis Inhibitors/therapeutic use
KW - Ranibizumab/therapeutic use
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U2 - 10.1007/s00417-021-05281-2
DO - 10.1007/s00417-021-05281-2
M3 - Article
C2 - 34463842
AN - SCOPUS:85114033797
SN - 0721-832X
VL - 260
SP - 47
EP - 54
JO - Graefe's Archive for Clinical and Experimental Ophthalmology
JF - Graefe's Archive for Clinical and Experimental Ophthalmology
IS - 1
ER -