Clinical Trials in Surgical Retina

Article initiated by:

Francesc March de Ribot, MD, PhD

All authors and contributors:

Leo A. Kim, MD, PhD, Francesc March de Ribot, MD, PhD

Assigned editor:

Koushik Tripathy, MD (AIIMS), FRCS (Glasgow)

Review:

Assigned status Update Pending

.

add
Contributing Editors:	add

Protocols AG and AH 2021

Chan CK, Mein CE, Glassman AR, Beaulieu WT, Calhoun CT, Jaffe GJ, Jampol LM, MacCumber MW, Maguire MG, Maturi RK, Salehi-Had H, Rofagha S, Sun JK, Martin DF; DRCR Retina Network. Pneumatic Vitreolysis with Perfluoropropane for Vitreomacular Traction with and without Macular Hole: DRCR Retina Network Protocols AG and AH. Ophthalmology. 2021 May 12:S0161-6420(21)00353-5. doi: 10.1016/j.ophtha.2021.05.005. Epub ahead of print. PMID: 33989683.

Objectives

The goal was to determine the effect of pneumatic vitreolysis (PVL) in eyes with vitreomacular traction (VMT) with and without full-thickness macular holes (FTMH).

Design

Randomized clinical trial compared PVL with C3F8 gas to observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH). Participants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, VA was 20/32 to 20/400. In Protocol AH, eyes had a FTMH (≤250 μm at the narrowest point) and VA of 20/25 to 20/400.

Main Outcome Measures

Central VMT release at 24 weeks (Protocol AG) and FTMH closure at 8 weeks (Protocol AH).

Limitations

The study had to be canceled for safety concerns; then, sample sizes were not met because of early termination. The original sample size calculations were based on anatomic, not visual, outcomes; thus, the power to detect modest differences between treatment groups were relatively low. The follow-up ended after 24 weeks, so data on long-term outcomes are unavailable.

Results

From 2018 to 2020, participants were enrolled in Protocol AG 46, and in Protocol AH, 35. The studies had to be terminated for safety concerns for the high number of retinal detachments (10%) and tears (1.6%). In Protocol AG at 24 weeks, the central VMT release was 78% in the PVL group and 9% in the sham group; the mean change in VA from baseline was 6.7 letters in the PVL group and 6.1 letters in the sham group. In Protocol AH at 8 weeks, the FTMH closure was 29% in the PVL group and, the mean change in VA from baseline was –1.5 letters.

Conclusions

PVL induced hyaloid release solving most of the cases of VMT and one-third of the FTMH. However, the studies were terminated early because of safety concerns related to retinal detachments.

Pearls for clinical practice

PVL for VMT and FTMH carries a high risk of complications.