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

• Status: Completed
• Trial end date: 2019-01-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Hospital
• Treatments: Ranibizumab

Criteria

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