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

Branch Retinal Vein Occlusion Clinical Trial

Official title:

The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054766
• Other study ID #: 121-2016001
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: January 28, 2019

Study information

• Verified date: December 2022
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 28, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Laser Photocoagulation
• Ranibizumab
• Retinal Vein Occlusion

Intervention

Procedure:
• Ranibizumab combined macular laser
subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.

Drug:
• Ranibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Pece A, Isola V, Piermarocchi S, Calori G. Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. Br J Ophthalmol. 2011 Jan;95(1):56-68. doi: 10.1136/bjo.2009.174060. Epub 2010 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity changes	comparing the changes of visual acuity between the two groups	one year