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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001436369
Enrollment
12
Registered
2017-10-10
Start date
2016-05-24
Completion date
2017-02-13
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 reac

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.

Sponsors

Hospital Oftalmológico de Sorocaba
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

inclusion criteria: BRVO less than or equal to 12 months; best corrected visual acuity (BCVA) > 20/320 and < 20/40; all participants must have macular edema.

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026