TY - JOUR
T1 - Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration in Vulnerable Fellow Eyes
T2 - A Randomized Clinical Trial
AU - PREVENT Study Group
AU - Chan, Clement K.
AU - Lalezary, Maziar
AU - Abraham, Prema
AU - Elman, Michael
AU - Beaulieu, Wesley Thomas
AU - Lin, Steven G.
AU - Khurana, Rahul N.
AU - Bansal, Alok S.
AU - Wieland, Mark R.
AU - Palmer, James D.
AU - Chang, Louis K.
AU - Lujan, Brandon J.
AU - Yiu, Glenn
N1 - Publisher Copyright:
© 2022 American Academy of Ophthalmology
PY - 2022/6
Y1 - 2022/6
N2 - Purpose: To determine whether prophylactic ranibizumab prevents the development of neovascular age-related macular degeneration (nAMD) in eyes with intermediate age-related macular degeneration (AMD) for patients with preexisting nAMD in their contralateral eye. Design: Multicenter randomized clinical trial. Participants: Adults aged 50 years and older with intermediate AMD (multiple intermediate drusen [≥63 μm and <125 μm] or ≥1 large drusen [≥125 μm] and pigmentary changes) in the study eye and nAMD in the contralateral eye. Intervention: Intravitreal ranibizumab injection (0.5 mg) or sham injection every 3 months for 24 months. Main Outcome Measures: Conversion to nAMD over 24 months (primary). Change in best-corrected visual acuity from baseline to 24 months (secondary). Results: Among 108 enrolled participants (54 [50%] in each group), all except 2 were non-Hispanic Whites, 61 participants (56%) were female, and the mean age was 78 years. The mean baseline visual acuity was 77.7 letters (Snellen equivalent 20/32). Conversion to nAMD over 24 months occurred among 7 of 54 eyes (13%) in both groups (ranibizumab vs. sham hazard ratio = 0.91 [95% confidence interval (CI), 0.32–2.59]; P = 0.86). At 24 months, the cumulative incidence of nAMD adjusted for loss to follow-up was 14% (95% CI, 4%–23%) in the ranibizumab group and 15% (95% CI, 4%–25%) in the sham group. At 24 months, the mean change in visual acuity from baseline was −2.1 letters (standard deviation, 5.4 letters) with ranibizumab and −1.4 letters (standard deviation, 7.7 letters) with sham (adjusted difference = −0.8 letters [95% CI, -3.7 to 2.2 letters]; P = 0.62). The proportion of eyes that lost at least 10 letters of visual acuity from baseline at 24 months was 2 of 39 (5%) with ranibizumab and 4 of 40 (10%) with sham. There were no serious ocular adverse events in either group. Conclusions: Quarterly dosing of 0.5 mg ranibizumab in eyes with intermediate AMD did not reduce the incidence of nAMD compared with sham injections; however, the study was likely underpowered given the 95% CI, and a clinically meaningful effect cannot be excluded. There also was no effect on visual acuity at 24 months. Other strategies to reduce neovascular conversion in these vulnerable eyes are needed.
AB - Purpose: To determine whether prophylactic ranibizumab prevents the development of neovascular age-related macular degeneration (nAMD) in eyes with intermediate age-related macular degeneration (AMD) for patients with preexisting nAMD in their contralateral eye. Design: Multicenter randomized clinical trial. Participants: Adults aged 50 years and older with intermediate AMD (multiple intermediate drusen [≥63 μm and <125 μm] or ≥1 large drusen [≥125 μm] and pigmentary changes) in the study eye and nAMD in the contralateral eye. Intervention: Intravitreal ranibizumab injection (0.5 mg) or sham injection every 3 months for 24 months. Main Outcome Measures: Conversion to nAMD over 24 months (primary). Change in best-corrected visual acuity from baseline to 24 months (secondary). Results: Among 108 enrolled participants (54 [50%] in each group), all except 2 were non-Hispanic Whites, 61 participants (56%) were female, and the mean age was 78 years. The mean baseline visual acuity was 77.7 letters (Snellen equivalent 20/32). Conversion to nAMD over 24 months occurred among 7 of 54 eyes (13%) in both groups (ranibizumab vs. sham hazard ratio = 0.91 [95% confidence interval (CI), 0.32–2.59]; P = 0.86). At 24 months, the cumulative incidence of nAMD adjusted for loss to follow-up was 14% (95% CI, 4%–23%) in the ranibizumab group and 15% (95% CI, 4%–25%) in the sham group. At 24 months, the mean change in visual acuity from baseline was −2.1 letters (standard deviation, 5.4 letters) with ranibizumab and −1.4 letters (standard deviation, 7.7 letters) with sham (adjusted difference = −0.8 letters [95% CI, -3.7 to 2.2 letters]; P = 0.62). The proportion of eyes that lost at least 10 letters of visual acuity from baseline at 24 months was 2 of 39 (5%) with ranibizumab and 4 of 40 (10%) with sham. There were no serious ocular adverse events in either group. Conclusions: Quarterly dosing of 0.5 mg ranibizumab in eyes with intermediate AMD did not reduce the incidence of nAMD compared with sham injections; however, the study was likely underpowered given the 95% CI, and a clinically meaningful effect cannot be excluded. There also was no effect on visual acuity at 24 months. Other strategies to reduce neovascular conversion in these vulnerable eyes are needed.
KW - Anti-VEGF
KW - Exudative age-related macular degeneration
KW - Geographic atrophy
KW - Intermediate age-related macular degeneration
KW - Nonexudative age-related macular degeneration
UR - http://www.scopus.com/inward/record.url?scp=85127896020&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127896020&partnerID=8YFLogxK
U2 - 10.1016/j.oret.2022.01.019
DO - 10.1016/j.oret.2022.01.019
M3 - Article
C2 - 35121216
AN - SCOPUS:85127896020
SN - 2468-7219
VL - 6
SP - 484
EP - 494
JO - Ophthalmology Retina
JF - Ophthalmology Retina
IS - 6
ER -