Branch Retinal Vein Occlusion, Laser Photocoagulation, Ranibizumab
Conditions
Keywords
Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor
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.
Interventions
PROCEDURERanibizumab 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.
DRUGRanibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity changes | one year | comparing the changes of visual acuity between the two groups |
Countries
China
Outcome results
None listed