Clinical trial NCT03054766: Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Branch Retinal Vein Occlusion
Ranibizumab
Laser Photocoagulation
Keywords: Laser Photocoagulation
Ranibizumab
Branch Retinal Vein Occlusion
Vascular Endothecial Growth Factor
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2017-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: visual acuity changes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Xiao-bing Yu, M.D
role: STUDY_CHAIR
References:
citation: 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.
citation: Song S, Yu X, Zhang P, Gu X, Dai H. Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial. BMC Ophthalmol. 2020 Jun 19;20(1):241. doi: 10.1186/s12886-020-01498-7.