A Randomized Clinical Trial of Pneumatic Vitreolysis with C₃F₈ for Vitreomacular Traction and A Single-Arm Study of Pneumatic Vitreolysis with C₃F₈ for Macular Hole: DRCR Retina Network Protocols AG and AH

Abstract

Purpose : To evaluate pneumatic vitreolysis (PVL) as treatment for vitreomacular traction (VMT) in eyes with and without full-thickness macular hole (FTMH)

Methods : Two multi-center studies conducted across 28 sites in the US. Protocol AG was a randomized clinical trial comparing PVL using C₃F₈ gas with observation (sham injection) in eyes with VMT less than 3000 μm in adhesion length and no FTMH. Protocol AH was a single-arm study assessing PVL using C₃F₈ gas for closure of FTMH no more than 250 μm wide at the narrowest point (AH). Baseline standardized visual acuity (VA) was required to be between 20/32 and 20/400 in AG, and between 20/25 and 20/400 in AH. PVL (AG and AH) or sham injection (AG only) was given at baseline; rescue vitrectomy could be performed if prespecified criteria were met. Primary outcome of AG was central VMT release without rescue at 24 weeks. Primary outcome of AH was FTMH closure without rescue at 8 weeks; central VMT release without rescue at 24 weeks was a secondary outcome. Change in VA from baseline, receipt of rescue vitrectomy, and ellipsoid zone integrity were secondary outcomes in both studies. Shape discrimination hyperacuity was tracked for AG. Rates of retinal tears and detachment were key safety outcomes.

Results : Protocol AG enrolled 46 participants with VMT; at baseline, mean age was 72 years, 67% were female, mean VA was 68.5 letters (Snellen equivalent 20/50), 7% had an epiretinal membrane in the central subfield, and median length of vitreomacular adhesion in the central subfield was 495 µm. Protocol AH enrolled 35 participants with VMT and FTMH; mean age was 69 years, 69% were female, mean VA was 55.8 letters (Snellen equivalent 20/80), 3% had an epiretinal membrane in the central subfield, and mean MH width at the narrowest point was 82 µm. Results have been analyzed and reviewed by the Data and Safety Monitoring Committee, but per National Eye Institute requirements for NIH-funded clinical trials, primary results cannot be made publicly available before publication. Submission and publication of the manuscript are anticipated before presentation of the results at the 2021 ARVO annual meeting.

Conclusions : Conclusions will follow from the results presented.

This is a 2021 ARVO Annual Meeting abstract.