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      Management of Large Submacular Hemorrhages Due to Exudative AMD Utilizing Pars Plana Vitrectomy, Subretinal Tissue Plasminogen Activator, and Gas Insertion Compared With Antivascular Endothelial Growth Factor Alone

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          Abstract

          Purpose:

          To assess the outcomes of patients with large submacular hemorrhage (SMH) due to age-related macular degeneration in this era of anti-vascular endothelial growth factor (VEGF).

          Methods:

          Retrospective analysis of 149 eyes of 149 patients receiving pars plana vitrectomy, subretinal tissue plasminogen activator, and gas injection (“surgical group”; n = 80) or anti-VEGF alone (“anti-VEGF group”; n = 69). Changes in visual acuity (VA), number of anti-VEGF injections, and percentage of patients with ≥3 line VA gains are compared between groups.

          Results:

          Patients in the surgical group had larger SMH than those in the anti-VEGF group, 30.35 versus 14.57 mm 2 ( P < .0001). Both groups experienced similar visual gains (−0.35 logarithm of the minimal angle of resolution [logMAR] vs −0.23 in logMAR, surgical vs anti-VEGF group; P = .36). The percentage of patients gaining ≥3 lines of VA was 55% in the surgical group and 54% in the anti-VEGF group. The surgical group achieved best-recorded VA sooner (3.7 compared to 4.6 months; P = .04) and required fewer injections (3.4 injections vs 4.7 in the anti-VEGF group; P = .001).

          Conclusion:

          Surgical intervention was favored for larger hemorrhages of shorter duration. Despite extensive hemorrhage and poor baseline VA, both groups showed similar rate of significant VA improvement.

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          Most cited references36

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          Ranibizumab for neovascular age-related macular degeneration.

          Philip J. Rosenfeld, David M Brown, Jeffrey Heier … (2006)
          Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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            Ranibizumab versus verteporfin for neovascular age-related macular degeneration.

            David M Brown, Peter K Kaiser, Mark Michels … (2006)
            We compared ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--with photodynamic therapy with verteporfin in the treatment of predominantly classic neovascular age-related macular degeneration. During the first year of this 2-year, multicenter, double-blind study, we randomly assigned patients in a 1:1:1 ratio to receive monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Of the 423 patients enrolled, 94.3% of those given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost fewer than 15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison). Visual acuity improved by 15 letters or more in 35.7% of the 0.3-mg group and 40.3% of the 0.5-mg group, as compared with 5.6% of the verteporfin group (P<0.001 for each comparison). Mean visual acuity increased by 8.5 letters in the 0.3-mg group and 11.3 letters in the 0.5-mg group, as compared with a decrease of 9.5 letters in the verteporfin group (P<0.001 for each comparison). Among 140 patients treated with 0.5 mg of ranibizumab, presumed endophthalmitis occurred in 2 patients (1.4%) and serious uveitis in 1 (0.7%). Ranibizumab was superior to verteporfin as intravitreal treatment of predominantly classic neovascular age-related macular degeneration, with low rates of serious ocular adverse events. Treatment improved visual acuity on average at 1 year. (ClinicalTrials.gov number, NCT00061594 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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              Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1.

              Carl Regillo, David M Brown, Prema Abraham … (2008)
              To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions. Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n = 63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at month 12. Mean changes from baseline VA at 12 months were -16.3, -1.6, and -0.2 letters for the sham, 0.3 mg, and 0.5 mg groups, respectively (P < or = .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the overall results. Few serious ocular or nonocular adverse events occurred in any group. Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or nonocular adverse events was low.
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                Author and article information

                Journal
                Title: Journal of VitreoRetinal Diseases
                Abbreviated Title: Journal of VitreoRetinal Diseases
                Publisher: SAGE Publications
                ISSN (Print): 2474-1264
                ISSN (Electronic): 2474-1272
                Publication date Created: January 2017
                Publication date (Electronic): January 26 2017
                Publication date (Print): January 2017
                Volume: 1
                Issue: 1
                Pages: 34-40
                Affiliations
                [1 ]The Retina Institute, St Louis, MO, USA
                [2 ]Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA
                Article
                DOI: 10.1177/2474126416680670
                SO-VID: 24d36af5-c554-4de6-b692-ba139231ee03
                Copyright © © 2017
                License:

                http://journals.sagepub.com/page/policies/text-and-data-mining-license

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