Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Branch Retinal Vein Occlusion

Treatments: Drug: Avastin intravitreal injection; Drug: Lucentis intravitreal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02033031

1-Sacu

Details and patient eligibility

About

Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.

Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME) and the development of neovascular glaucoma. The occurence of ME is the main reason for visual loss and frustrates visual recovery among patients with both central or branch RVO.

Therapeutic options that have been used and discussed over the years are the treatment with anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution. Furthermore, surgical options like vitrectomy and radial optic neurotomy were used. Panretinal photocoagulation and grid pattern photocoagulation had established as additional tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of these different treatment options could not be verified and remains mostly unknown.

Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE). Unfortunately, often high numbers of re-treatments become necessary over the years. In our knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are important, as the mean age < 70 years with an onset of BRVO has been estimated in about 60% of all cases. In addition, most patients with regard to the application of anti-VEGF treatment in real clinical setting, there is only rare experience concerning need of optimum time duration for follow-up at the departments. Hence, the present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.

Full description

This cross-sectional study evaluates a series of patients with ME due to RVO who were available for at least 4 years' follow-up examination. The patients received either intravitreal ranibizumab (IVR) or bevacizumab (IVB) in a flexible dosing regimen

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Macular edema secondary to Branch retinal vein occlusion

Exclusion criteria

• Aphakia, Glaucoma

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

Lucentis

Active Comparator group

Description:

PRN intravitreal injection of Lucentis

Treatment:

Drug: Lucentis intravitreal injection

Avastin

Active Comparator group

Description:

PRN intravitreal injection of Lucentis

Treatment:

Drug: Avastin intravitreal injection