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A prospective, randomized, single-blind, multicenter case-control clinical trial comparing Ozurdex and ranibizumab in the treatment of Coats' disease

A prospective, randomized, single-blind, multicenter case-control clinical trial comparing Ozurdex and ranibizumab in the treatment of Coats' disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094335
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Coats' disease

Interventions

Ozurdex with laser therapy group:intra-vitreal injection of Ozurdex and combined with laser therapy
Ranibizumab with laser therapy group:intra-vitreal injection of ranibizumab and combined with laser therapy

Sponsors

Eye and ENT Hospital, Shanghai Medical College, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with severe type Coats' disease: Patients in stage 2B with exudation involving more than two quadrants, and patients in stages 3A and 3B. 2. Patients and their families must be able to provide a signed informed consent form, voluntarily participate in the study; and be able to comply with all research procedures and assessments during the study period.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be eligible for inclusion in this study. To ensure that the study population represents all eligible patients, investigators shall not apply additional exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. A history of stroke, cerebral infarction, peripheral vascular disease, angina, or myocardial infarction within the 6 months prior to the screening period; 3. Received ocular corticosteroids, any type of anti-vascular endothelial growth factor (anti-VEGF) drugs, or undergone any other ocular surgery within the 3 months prior to the screening period; 4. Uncontrolled glaucoma (IOP of 21mmHg or higher), neovascularization of the iris, or neovascular glaucoma in either eye at the time of screening or baseline; 5. Active infectious diseases in either eye at the time of enrollment, or intraocular inflammation, active or suspected periocular infection; 6. Patients who are unable to comply with the study or follow-up procedures.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity;The rate of retinal abnormal vascular regression;

Secondary

MeasureTime frame
Change of foveal thickness;Frequency of intra-vitreal injections;The rate of subretinal exudation absorption;The rate of disease progression ;The frequency of retinal laser therapy;

Countries

China

Contacts

Public ContactXin Huang

Eye and ENT Hospital, Shanghai Medical College, Fudan University

fd2017huangxin@163.com+86 138 1890 2665

Outcome results

None listed

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