Although equivalence cannot be determined, this superiority study suggests that pars plana vitrectomy (PPV) does not offer significantly better outcomes when compared to pneumatic displacement for the treatment of submacular hemorrhage (SMH) secondary to wet AMD.
Study design
This was a randomized, open-label, multicenter, superiority study involving patients with recent symptoms (≤14 days) of SMH secondary to wet AMD. Included patients demonstrated blood predominantly overlying the retinal pigment epithelium (RPE), a minimum RPE thickness of >100 μm, and an SMH diameter >2 optic disc diameters (DD). Patients were randomized to undergo surgery (vitrectomy, subretinal tPA, and 20% SF6 tamponade) or pneumatic displacement (0.05 ml intravitreal tPA [50 μg] and 0.3 ml intravitreal pure SF6), followed by head-upright positioning with the face forward at 45° for 3 days after intervention. Both groups received intravitreal ranibizumab.
Outcomes
Seventy-eight of the 90 patients (86.7%) completed the 3-month efficacy endpoint visit. At three months, there was no significant difference in the mean visual acuity change from baseline between the surgery group (+16.8 letters) and the pneumatic displacement group (+16.4 letters) and no significant differences in quality-of-life questionnaire responses. Similar findings were noted at the 6-month follow-up. Recurrence of SMH was more common in the pneumatic displacement group (13.6%) than in the surgery group (4.4%). In contrast, retinal detachments were more common in the surgery group (8.8%) than in the pneumatic displacement group (0%).
Limitations
The surgery group included a greater proportion of patients with large SMHs (diameter >5 DD) than the pneumatic displacement group (43.9% vs 27.5%, respectively). Surgery-group patients also had thicker SMHs than patients in the pneumatic displacement group (1098 μm vs 966 μm, respectively). Given these variations in the size and thickness of SMHs, it is possible that there would also be differences in outcomes and that focusing on larger SMHs as part of the enrollment criteria could impact the results.
Clinical significance
Both surgical and pneumatic displacement of SMHs appear to be options for patients with wet AMD who experience submacular hemorrhage. Further research is needed to assess if very large and thick lesions would benefit from one particular intervention.
Financial Disclosures: Dr. Ajay Kuriyan discloses financial relationships with 4DMT, Adverum, Annexon, National Eye Institute, Novartis, Alcon Pharmaceuticals (Grant Support); Alimera Sciences, Allergan, Bausch + Lomb, EyePoint Pharmaceuticals (Consultant/Advisor); Iveric Bio, Optos (Lecture Fees/Speakers Bureau); Lumata Health, Recens Medical (Consultant/Advisor, Private Equity/Stock Holder); Spark Therapeutics (Consultant/Advisor, Lecture Fees/Speakers Bureau); Genentech (Consultant/Advisor, Lecture Fees/Speakers Bureau, Grant Support).