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A randomized, double blind, controlled trials for assessing the efficacy of 0.5 mg ranibizumab only in subject with macular laser combined due to diabetic branch retinal vein occlusion

A randomized, double blind, controlled trials for assessing the efficacy of 0.5 mg ranibizumab only in subject with macular laser combined due to diabetic branch retinal vein occlusion

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014289
Enrollment
Unknown
Registered
2018-01-04
Start date
2016-09-21
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Branch vein occlusion macular edema

Interventions

1:razorumab combined with macular laser photocoagulation
2:razorumab alone

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 76 Years

Inclusion criteria

Inclusion criteria: Patient selection criteria: 1) Informed consent must be signed before performing any study-related assessments; 2) Adult males or females aged 18 years or older; Eye selection criteria: Research Institute 3) Within 12 months prior to the screening visit, the study eye was diagnosed with visual impairment due to macular edema secondary to BRVO; 4) BCVA 24 to 73 ETDRS letters for screening and baseline visits; 5) The central retinal thickness measured by OCT was> 250 um; Contralateral eye 6) In the screening, the contralateral fundus BCVA = 34 ETDRS letters.

Exclusion criteria

Exclusion criteria: Patients who meet one of the following criteria are not eligible for inclusion in this study: 1) Research or follow-up procedures can not be followed; 2) Pregnant or lactating women, as well as women who do not take effective contraceptive methods are fertile women; 3) Screening The patients had a history of stroke or myocardial infarction within 3 months before the visit; 4) Renal failure or creatinine levels> 2.0 mg / dl; 5) Uncontrolled high blood pressure; 6) Active eye infections or intraocular inflammation of any eye; 7) iris neovascularization or neovascular glaucoma in any one eye; 8) any eye of uveitis or vitreous macular traction, macular epiretinal history; 9) In the first 3 months before the baseline visit, either eye received anti-angiogenic drug therapy; 10) studied eye glaucoma or IOP >24 mmHg; 11) study of diabetic retinopathy; 12) Other test drugs were used within 30 days before baseline visit; systemic anti-VEGF drugs were used within 6 months prior to baseline visit; 13) Study eyes received laser photocoagulation or intraocular surgery within 3 months prior to baseline; 14) with a history of lens research and aphakic or pseudo-crystalline eyes (within 3 months prior to screening) with vitreous corticosteroid treatment history; 15) Study the history of vitrectomy.

Design outcomes

Primary

MeasureTime frame
Edema height;

Countries

China

Contacts

Public ContactYu Xiaobing

Beijing Hospital

yuxiaobing@sina.com+86 13611183056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026