Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO

Beijing Hospital

Status: Completed

Conditions: Laser Photocoagulation; Ranibizumab; Branch Retinal Vein Occlusion

Treatments: Drug: Ranibizumab; Procedure: Ranibizumab combined macular laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03054766

121-2016001

Details and patient eligibility

About

To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.

Full description

To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.

The result of the trial will be used to support new therapy in the BRVO in China.

Enrollment: 80 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent
2. Male or female Chinese patients ≥ 18 years of age with BRVO
3. Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye

Exclusion criteria

1. Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
2. Stroke or myocardial infarction less than 3 months prior to screening visit
3. Renal failure or creatinine levels > 2.0 mg/dl
4. Uncontrolled hypertension
5. Active ocular infection or intraocular inflammation in any eye
6. Neovascularization of the iris or neovascular glaucoma in any eye
7. History of uveitis or vitreomacular traction in any eye
8. Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
9. Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
10. Active proliferative diabetic retinopathy in study eye
11. Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
12. Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
13. History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
14. History of vitrectomy in study eye
15. Other protocol defined inclusion /exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Ranibizumab only

Experimental group

Description:

Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Sham macular laser

Treatment:

Drug: Ranibizumab

Ranibizumab combined macular laser

Experimental group

Description:

Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation

Treatment:

Procedure: Ranibizumab combined macular laser

Drug: Ranibizumab