Browse by author
Lookup NU author(s): Alex Mehta, Professor David SteelORCiD
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
Copyright © 2024 American Medical Association.Importance: Evidence is limited to support therapies to treat submacular hemorrhage (SMH) secondary to neovascular age-related macular degeneration (AMD) as an adjunct to anti-vascular endothelial growth factor therapy (anti-VEGF). Objective: To determine if intravitreal tissue plasminogen activator (TPA) or gas improves visual acuity or promotes resolution of SMH secondary to neovascular AMD in eyes treated with ranibizumab. Design, Setting, and Participants: This was a double-masked, sham-controlled, factorial randomized clinical trial and feasibility study that recruited participants from June 2014 to March 2019, with 12 months' follow-up. Included in the trial were patients from 4 UK vitreoretinal units who had fovea-involving SMH of at least 1 disc area secondary to neovascular AMD and were evaluated within 14 days of onset. Interventions: Study eyes received baseline ranibizumab and were then randomized 2:1:1:1 to 1 of 4 intravitreal treatments: sham injection, perfluoropropane (C3F8), TPA, or combined C3F8 and TPA (C3F8 + TPA). All eyes received monthly pro re nata ranibizumab therapy over 12 months. Outcome assessors were masked to intervention assignment. Main Outcome and Measure: Best-corrected visual acuity (BCVA) at month 3. Results: Fifty-three of 56 participants (95%; mean [SD] age, 81.5 [8.1] years; 33 female [59%]) reached the primary end point. Study eyes were randomized to the following intravitreal treatments: sham injection (n = 23), C3F8 (n = 11), TPA (n = 11), or C3F8 + TPA (n = 11). On factorial analysis, the combined TPA groups had significantly better month 3 mean logMAR BCVA than those not receiving TPA: 0.66 vs 0.98 (μd = -0.32; 95% CI, -0.58 to -0.07; P =.02). There was no statistically significant difference comparing groups that did vs did not receive C3F8: 0.80 vs 0.90 (μd = -0.11; 95% CI, -0.37 to 0.16; P =.43). The combined TPA groups were less likely to have SMH present at month 1 (10 of 18 [55.6%] vs 21 of 24 [87.5%]; P =.03), a benefit not evident in the combined gas groups. The mean logMAR BCVA at 3 months was not significantly different between the groups: monotherapy control, 0.99; C3F8, 0.97 (vs control μd = -0.02; 95% CI, -0.48 to 0.44); TPA, 0.70 (vs control μd = -0.29; 95% CI, -0.79 to 0.21); combined C3F8 and TPA, 0.71 (vs control μd = -0.36; 95% CI, -0.82 to 0.11); P =.11. No safety differences were identified across the treatment groups. Conclusions and Relevance: Results of this randomized clinical trial suggest that TPA may increase the chance of visual acuity gain when added to ranibizumab therapy for neovascular AMD in eyes with SMH, warranting consideration of additional clinical trials.
Author(s): Murphy GSP, Saleh A, Ayis S, Cheema MR, Mehta A, Steel DH, Membrey L, Costen M, Jackson TL
Publication type: Article
Publication status: Published
Journal: JAMA Ophthalmology
Year: 2024
Volume: 142
Issue: 12
Online publication date: 17/10/2024
Acceptance date: 25/08/2024
ISSN (print): 2168-6165
ISSN (electronic): 2168-6173
Publisher: American Medical Association
URL: https://doi.org/10.1001/jamaophthalmol.2024.4297
DOI: 10.1001/jamaophthalmol.2024.4297
PubMed id: 39418015
Altmetrics provided by Altmetric
