1. Preoperative Characteristics
TRABECULECTOMY WITH MMC VERSUS A SINGLE INTRACAMERAL INJECTION OF BEVACIZUMAB: ONE YEAR COMPARATIVE RESULTS
Gerasimos Kopsinis, M.D., Ph.D.1, Dimitrios Tsoukanas, M.D.1, Konstantina Platari, M.D.1, Dimitra Kopsini, M.S.2, Theodoros Filippopoulos, M.D.1
1. Athens Vision Eye Institute, Athens, Greece
2. National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
Background: Glaucoma is usually treated with intraocular pressure (IOP) lowering medications but poor compliance with medications, drug side effects or refractory disease despite maximum tolerated medical therapy can lead to progressive optic nerve damage that needs surgical intervention. For the last decades standard guarded trabeculectomy with antimetabolites has been, and still remains, the most popular surgical option in glaucoma .The main reason for failure in trabeculectomy is subconjunctival scarring of the filtering bleb because of progressive fibroblast migration/proliferation, collagen deposition and angiogenesis. Although 5-fluororacil and mitomycin C (MMC) have revolutionized glaucoma surgery, they can cause complications. Vascular endothelial growth factor affects wound healing after trabeculectomy by inducing fibroblast proliferation. This study aims to investigate whether guarded trabeculectomy with intracameral bevacizumab is superior to standard guarded trabeculectomy with MMC, in terms of hypotensive effect and complication rates.
Purpose: To compare the efficacy of standard trabeculectomy with mitomycin C to trabeculectomy with intracameral injection of Bevacizumab.
Methods: Randomized, prospective, comparative case series of 41 eyes with uncontrolled glaucoma. 19 eyes (group A) underwent trabeculectomy with intracameral bevacizumab (1.25 mg) whereas 22 eyes (group B) underwent trabeculectomy with subconjuctival MMC (.02% - 2 minutes). Recorded parameters included: age, type of glaucoma, IOP, number of medications before and after surgery and complications. First year follow up data were analyzed.
Results: Average age was years and years respectively (p=.15 t-test). Average preop IOP was and mmHg respectively (p=.09 t-test). Average preop number of medications was and respectively (p=1.14 t-test). Average IOP and number of medications decreased significantly in both groups at all respective time points as compared to preop data (p<.001 t-test). At 12 months mean IOP was and mmHg respectively (p=.68 t-test) and the number of medications decreased to 0.2±0.7 and 0.4±1 respectively (p=.46). IOP was significantly lower in group A 1 week (p=.01) and 1 month (p=.05) after surgery. Significantly higher % reduction in IOP in group A 1 week (p=.03), 1 month (p=.03) and 3months (p=.03) after surgery was also noted. Employing Tube Versus Trabeculectomy (TVT) study criteria the rate of complete success at 12 months was 89.5% in group A and 77.3% in group B (p=.27 log-rank chi-square). We reported zero cases of persistent hypotony, suprachoroidal hemorrhage, blebitis or delayed aqueous leak.
Conclusion: Anti-angiogenic therapy appears promising as an addition to standard guarded trabeculectomy, warranting validation as alternative to standard care.
Preoperative Characteristics
Bevacizumab
MMC
p Value
Eyes included 19 22
Eyes with 12 months follow-up
Male/Female
10/9
9/13
Mean Age ± SD (years)
74.1 ± 10.5
69 ± 11.4
0.15
Mean # of medications ± SD
3.3 ± 0.8
3.7 ± 0.7
0.14
Mean IOP ± SD (mmHg)
33.6 ± 11.3
28.4 ± 8.1
0.09
Mean MD ± SD (dB)
-13.8 ± 9.8
-13.9 ± 8.4
0.98
Mean CCT ± SD (dB)
527 ± 24.7
545.1 ± 33.3
0.08
Mean cup/disk ratio ± SD (dB)
0.6 ± 0.3
0.7 ± 0.2
0.45
Lens Status
Pseudophakia, (%)
1 (5%)
3 (14%)
0.37
Type of Glaucoma
POAG
13 (69%)
14 (63%)
0.75
PXFG
5 (26%)
5 (23%)
0.79
Postoperative Measures
Bevacizumab
MMC
p Value
Mean IOP ± SD at 1 week (mmHg)
9.3 ± 2.6
11.2 ± 2.2
0.01*
Mean IOP ± SD at 1 month (mmHg)
11 ± 3.4
13.1 ± 3.5
0.05*
Mean IOP ± SD at 3 months (mmHg)
12.2 ± 2.7
14 ± 3.3
0.07
Mean IOP ± SD at 6 months (mmHg)
13.6 ± 3.4
15.4 ± 4.4
0.16
Mean IOP ± SD at 12 months (mmHg)
14.4 ± 2.2
14 ± 3.2
0.68
% IOP reduction ± SD at 1 week
68.1 ± 15.4
57.3 ± 14.9
0.03*
% IOP reduction ± SD at 1 month
62.7 ± 16.8
51.3 ± 14.7
% IOP reduction ± SD at 3 months
59.4 ± 16.4
48.1 ± 15.2
% IOP reduction ± SD at 6 months
54.4 ± 19.2
42.9 ± 19.9
% IOP reduction ± SD at 12 months
51.9 ± 19.1
47.4 ± 17.6
0.44
Mean # of medications ± SD at 12 months
0.2 ± 0.7
0.4 ± 1
0.46
Qualified Success Rate at 12 months
100%
95.5%
0.34
Complete Success Rate at 12 months
89.5%
77.3%
0.27
Early Hypotony Incidence, (%)
3 (16%)
2 (9%)
0.53
Bleb Needlings, (%)
3 (14%)
0.15
5-FU Injections, (%)
1 (5%)
4 (18%)
0.21
Figure 1(on the left): Course of Average IOP ± Standard Error of Measurement for the Bevacizumab and MMC groups. Error Bars represent standard error of measurement. IOP differed between groups significantly at 1 week and 1 month. *p ≤ 0.05
Figure 2(on the right): Kaplan-Meier Survival Curves for complete and qualified success in the Bevacizumab and MMC cohorts according to TVT study success criteria.
References
1.Cheng JW, et al. Cochrane Database Syst Rev.2016.
2. Fakhraie G, et al. J Glaucoma 2016 Mar;25(3):e 182-8
3. Wandewalle E, et al. Br J Ophthalmol Jan;98(1):73-8
4. Van Bergen T, et al. Acta Ophthalmol Nov;93(7):667-78
[i] The authors have no financial or proprietary interest, and do not receive payment as consultants, reviewers or evaluators in the above-mentioned medications and material.