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A post-hoc analysis of the HARBOR trial suggest a greater proportion of ranibizumab-treated eyes with nAMD gained/maintained visual acuity at SRF resolution.
New findings from a post hoc analysis of the phase 3 HARBOR trial indicate a greater proportion of eyes with neovascular age-related macular degeneration (nAMD) treated with ranibizumab maintained or gained visual acuity at subretinal fluid (SRF) resolution.
The data from the analyses report approximately 9% of eyes lost vision during SRF resolution and these eyes had reduced final visual acuity gains at 12 and 24 months.
“Further analyses are warranted to investigate potential underlying factors and discuss the treatment implications if confirmed,” wrote study author Manuel J. Amador-Patarroyo, MD, Medical Director, Medical Affairs Ophthalmology, Genentech.
The objective of Amador-Patarroyo and colleagues’ analysis was to determine the effects of SRF resolution on visual acuity in nAMD using eyes from the HARBOR trial. The HARBOR trial was a double-masked, randomized, active treatment–controlled trial of ranibizumab carried out from January 2020 to July 2021.
It included treatment-naive patients with nAMD and active subfoveal choroidal neovascularization, for a total of 1,097 patients. Then, multiple intervention arms were pooled for the analysis if SRF was present at baseline and intraretinal fluid/SRF resolved during the study, based on spectral-domain optical coherence tomography (OCT), for a total of 349 patients.
The intervention was three monthly loading doses followed by intravitreal injections of 0.5-mg or 2.0-mg ranibizumab administered monthly or pro re nata over 24 months. Main outcomes for the analysis consisted of the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between the month before SRF resolution and the month of SRF resolution detection.
Additionally, visual outcomes at months 12 and 24 were analyzed in eyes without SRF recurrence after SRF resolution. The proportion of patients who lost ≤4 letters were considered as vision gainers or maintainers and those who lost ≥5 letters were considered as vision losers.
Out of the 349 patients, 32 (9%) were observed to have lost ≥5 ETDRS letters (mean, -9.9 letters [95% CI, -12.0 to –7.9]) and 317 (91%) of the eyes gained or maintained BCVA (mean, 6.1 letters [95% CI, 5.3 to 6.8]) between the month before SRF resolution and the month of SRF resolution.
Investigators noted no differences in baseline ocular characteristics between patients groups. Among the eyes without SRF recurrence after SRF resolution (64%; 224 of 349), eyes that lost ≥5 ETDRS letters had reduced visual outcome gains from baseline to month 12 versus those that gained or maintained letters (1.4 vs. 12.9 letters), as well as at month 24 (0.0 vs. 12.6 letters).
The abstract, “Subretinal Fluid Resolution and Visual Acuity in Patients with Neovascular Age-Related Macular Degeneration: A HARBOR Post Hoc Analysis,” was published in Ophthalmology Retina.