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A prospective randomized controlled trial for comparing 1+prn and 3+prn regimen in the treatment of macular edema secondary to branch retinal vein occlusion

A prospective randomized controlled trial for comparing 1+prn and 3+prn regimen in the treatment of macular edema secondary to branch retinal vein occlusion

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038086
Enrollment
Unknown
Registered
2020-09-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2020-11-24

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

Conditions

branch retinal vein occlusion

Interventions

1+PRN:Patients were treated with one injection of intravitreal ranibizumab (IVR) and further IVR injections were administered as needed.
3+PRN:Patients were treated with three consecutive monthly injections of IVR and further IVR injections were administered as needed.

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The willingness to participate in the study and sign informed consent; 2. Patients >=18 years old, male or female; 3. The study eye must meet the following criteria: 1) diagnosis of macular edema secondary to BRVO with a duration of less than six months 2) the best-corrected vision acuity (BCVA) score >=19 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent of >=20/400); 3) central retinal thickness >250 um on OCT examination; 4) no obvious optical media opacity or myosis to influence ocular fundus examination. Note: only one eye of each participant is chosen. If both eyes meet the inclusion criteria, the researchers will decide the study eye from the medical point of view.

Exclusion criteria

Exclusion criteria: 1. With active retinal or iris neovascularization; 2. concomitant macular diseases that may influence the visual acuity including epiretinal membrane, vitreomacular traction syndrome and macular atrophy; 3. a history of other ocular diseases that can cause macular edema including wet age-related macular denegation, diabetic retinopathy, uveitis and other intraocular inflammatory diseases; 4. eyes with cataract that need to receive cataract surgeries within next 12 months after the baseline visit; 5. treatment for macular edema including intravitreal injection of corticosteroids or anti-VEGF agents before; 6. with active periocular or ocular inflammation including blepharitis, infective conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis; 7. uncontrolled intraocular pressure ( > 30 mmHg after anti-glaucoma surgeries or received glaucoma filtering surgery); 8. type I or II diabetes mellitus; 9. use of any systemic anti-VEGF agents within 6 months before the baseline visit; 10. with severe asthma or allergy or systemic diseases that cannot receive FFA examination or intravitreal ranibizumab; 11. confirmed uncontrolled blood pressure defined as a systolic value of > 160 mmHg or a diastolic value of > 90 mmHg at the screening or baseline visit; 12. with severe cardiovascular and cerebrovascular diseases including myocardial infarction cerebral infarction, DIC and diseases of bleeding tendency; 13. with confirmed immunological diseases that need to be treated; 14. under other clinical trials at the baseline visit or within 6 months before the baseline visit; 15. refusal or inability to attend regular visits; 16. pregnant or nursing women and women not on reliable contraception; 17. with active mental disorders; 18. other circumstances that researchers think the patients should be excluded.

Design outcomes

Primary

MeasureTime frame
BCVA;CRT;number of IVR;

Secondary

MeasureTime frame
BCVA;CRT;BCVA;CRT;

Countries

China

Contacts

Public ContactQing Chang

Eye & ENT Hospital of Fudan University

qngchang@aliyun.com+86 13916827595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026