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Randomized Controlled Trial
. 2021 Nov;128(11):1592-1603.
doi: 10.1016/j.ophtha.2021.05.005. Epub 2021 May 12.

Pneumatic Vitreolysis with Perfluoropropane for Vitreomacular Traction with and without Macular Hole: DRCR Retina Network Protocols AG and AH

Clement K Chan  1 , Calvin E Mein  2 , Adam R Glassman  3 , Wesley T Beaulieu  4 , Claire T Calhoun  4 , Glenn J Jaffe  5 , Lee M Jampol  6 , Mathew W MacCumber  7 , Maureen G Maguire  8 , Raj K Maturi  9 , Hani Salehi-Had  10 , Soraya Rofagha  11 , Jennifer K Sun  12 , Daniel F Martin  13 ; DRCR Retina Network
Affiliations
Randomized Controlled Trial

Pneumatic Vitreolysis with Perfluoropropane for Vitreomacular Traction with and without Macular Hole: DRCR Retina Network Protocols AG and AH

Clement K Chan et al. Ophthalmology. 2021 Nov.

Abstract

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

Design: Two multicenter (28 sites) studies: a randomized clinical trial comparing PVL with observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH).

Participants: Participants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, visual acuity (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.

Methods: Pneumatic vitreolysis using perfluoropropane (C3F8) gas.

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

Results: From October 2018 through February 2020, 46 participants were enrolled in Protocol AG, and 35 were enrolled in Protocol AH. Higher than expected rates of retinal detachment and tear resulted in early termination of both protocols. Combining studies, 7 of 59 eyes (12% [95% CI, 6%-23%]; 2 eyes in Protocol AG, 5 eyes in Protocol AH) that received PVL developed rhegmatogenous retinal detachment (n = 6) or retinal tear (n = 1). At 24 weeks in Protocol AG, 18 of 23 eyes in the PVL group (78%) versus 2 of 22 eyes in the sham group (9%) achieved central VMT release without rescue vitrectomy (adjusted risk difference, 66% [95% CI, 44%-88%]; P< 0.001). The mean change in VA from baseline at 24 weeks was 6.7 letters in the PVL group and 6.1 letters in the sham group (adjusted difference, -0.8 [95% CI, -6.1 to 4.5]; P = 0.77). In Protocol AH, 10 of 35 eyes (29% [95% CI, 16%-45%]) achieved FTMH closure without rescue vitrectomy at 8 weeks. The mean change in VA from baseline at 8 weeks was -1.5 letters (95% CI, -10.3 to 7.3 letters).

Conclusions: In most eyes with VMT, PVL induced hyaloid release. In eyes with FTMH, PVL resulted in hole closure in approximately one third of eyes. These studies were terminated early because of safety concerns related to retinal detachments and retinal tears.

Keywords: C(3)F(8); DRCR Retina Network; Pneumatic vitreolysis; Vitreomacular traction macular hole.

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Conflict of interest statement

Potential financial conflicts of interests and other financial disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

Figures

Figure 1.
Figure 1.. Study Flow Diagram.
A. Randomization and participant flow in Protocol AG. Participants were not formally screened before obtaining informed consent. Reasons for ineligibility were not systematically collected. Visit completion at 24 weeks was prespecified as completion of any study visit from 18 to 40 weeks. B. Enrollment and participant flow in Protocol AH. Participants were not formally screened before obtaining informed consent. Reasons for ineligibility were not systematically collected. Visit completion at 24 weeks was prespecified as completion of any study visit from 18 to 40 weeks. a One eye that did not have full-thickness macular hole was enrolled, received PVL, and completed the 24-week visit but is not included in any analyses or subsequent levels in the flowchart PVL = pneumatic vitreolysis
Figure 1.
Figure 1.. Study Flow Diagram.
A. Randomization and participant flow in Protocol AG. Participants were not formally screened before obtaining informed consent. Reasons for ineligibility were not systematically collected. Visit completion at 24 weeks was prespecified as completion of any study visit from 18 to 40 weeks. B. Enrollment and participant flow in Protocol AH. Participants were not formally screened before obtaining informed consent. Reasons for ineligibility were not systematically collected. Visit completion at 24 weeks was prespecified as completion of any study visit from 18 to 40 weeks. a One eye that did not have full-thickness macular hole was enrolled, received PVL, and completed the 24-week visit but is not included in any analyses or subsequent levels in the flowchart PVL = pneumatic vitreolysis
Figure 2.
Figure 2.. Time to central vitreomacular traction release without rescue vitrectomy through 24 weeks by treatment group in Protocol AG.
The cumulative probability of central vitreomacular traction release without rescue vitrectomy at 24 weeks was 76% (95% CI, 57%–90%) in the PVL group and 9% (95% CI, 2%–32%) in the sham group (hazard ratio = 19.06 [95% CI, 4.64–78.30], P<.001). PVL = pneumatic vitreolysis.
Figure 3.
Figure 3.. Visual acuity and change in visual acuity through 24 weeks by treatment group in Protocol AG.
The top panel shows visual acuity letter score and the bottom panel shows visual acuity letter score change from baseline. Orange circles and blue squares represent the mean for the PVL and sham groups, respectively, and error bars represent 95% confidence intervals. The number of eyes contributing data at each visit is given below the plot. PVL = pneumatic vitreolysis
Figure 4.
Figure 4.. Time to macular hole closure without rescue vitrectomy through 24 weeks in Protocol AH.
The cumulative probability of macular hole closure without rescue vitrectomy through 24 weeks was 29% (95% CI, 17%–47%). PVL = pneumatic vitreolysis.
Figure 5.
Figure 5.. Time to vitreomacular traction release without rescue vitrectomy through 24 weeks in Protocol AH.
The cumulative probability of central vitreomacular traction release without rescue vitrectomy through 24 weeks was 94% (95% CI, 83%–99%). PVL = pneumatic vitreolysis.
See this image and copyright information in PMC

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