CompletedPhase 4ACTRN12617001436369

Anti-VEGF treatment associated with laser photocoagulation in patients with macular edema due to branch vein occlusion

Efficacy of bevacizumab and laser photocoagulation for preventing the recurrence of macular edema due to branch vein occlusion.


Sponsor

Hospital Oftalmológico de Sorocaba

Enrollment

15 participants

Start Date

May 24, 2016

Study Type

Interventional

Conditions

Summary

Purpose: To evaluate the use of up to six monthly treatments of anti-angiogenesis therapy followed by laser photocoagulation reduces the recurrence rate of macular edema secondary to branch retinal vein occlusion (BRVO) after maximal visual acuity (VA) stabilization. Methods: patients with macular edema due to BRVO were included. Main inclusion criteria: BRVO less than or equal to 12 months; best corrected visual acuity (BCVA) > 20/320 and < 20/40. Main exclusion criteria: previous intravitreous drugs or macular laser treatment, macular surgery, cataract extraction in the previous 6 months, macular edema due to other causes. Complete ophthalmological examination was performed at baseline, including optical coherence tomography (OCT) and fluorescein angiography (FA). Enrolled patients were seen monthly up to the sixth month. Patients were treated with 1.25 mg intravitreous bevacizumab up to six injections. BCVA and OCT were measured in each visit. After the third injection, if the BCVA reached a plateau (same measurement of visit 3) or achieved 20/20 and there was no foveal OCT fluid, the injections were withheld and laser was applied at the same visit. Patient was then followed monthly with BCVA and OCT. If after the third injection the patient did not reach the VA plateau and/or had foveal fluid on OCT, the injections were continued until reaching the plateau or VA 20/20 or up to the maximum of 6 injections. Retreatment criteria were: central macular thickness (CMT) > 300 microns with presence of foveal fluid and/or loss of 10 or more letters BCVA. If retinal neovascularization developed, laser photocoagulation would be applied. This study was approved by Ethics Committee of the Institution.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

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Interventions

Patients with macular edema due to branch vein retina occlusion (BRVO) were included. Complete ophthalmological examination was performed at baseline, including optical coherence tomography (OCT) and

Patients with macular edema due to branch vein retina occlusion (BRVO) were included. Complete ophthalmological examination was performed at baseline, including optical coherence tomography (OCT) and fluorescein angiography (FA). Enrolled patients were seen monthly up to the sixth month. Patients were treated with 1.25 mg intravitreous bevacizumab up to six injections. Best corrected visual acuity (BCVA) and OCT were measured in each visit. After the third injection, monthly, if the BCVA reached a plateau (same measurement of visit 3) or achieved 20/20 and there was no foveal OCT fluid, the injections were withheld and laser was applied at the same visit (once only). The type of laser is the argon laser. Macular photocoagulation settings were 50 to 100 um spot size, 50 to 100 ms pulse duration, and power titrated to achieve mild burn intensities. Patient was then followed monthly with BCVA and OCT. If after the third injection the patient did not reach the visual acuity (VA) plateau and/or had foveal fluid on OCT, the injections were continued until reaching the plateau or VA 20/20 or up to the maximum of 6 injections monthly. Retreatment criteria were: central macular thickness (CMT) > 300 microns with presence of foveal fluid and/or loss of 10 or more letters BCVA. If retinal neovascularization developed, laser photocoagulation would be applied.


Locations(1)

São Paulo, Brazil

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ACTRN12617001436369