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Completed
NCT07690800
Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage
Conditions: Diabetic Vitreous Hemorrhage, Intravitreal Injections, Ranibizumab
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 30
Sponsor: Benha University
Location: Benha University Banhā Benha
Summary
This prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. The study aims to assess the effectiveness of ranibizumab in improving visual acuity, promoting vitreous hemorrhage clearance, reducing the need for pars plana vitrectomy, and evaluating treatment-related safety.
Eligible adult patients with diabetic vitreous hemorrhage will receive intravitreal ranibizumab according to the study protocol and will be followed for 3 to 6 months with serial ophthalmic examinations. Outcome measures include changes in best-corrected visual acuity, vitreous hemorrhage severity, treatment-related complications, and the proportion of patients requiring vitrectomy. Panretinal photocoagulation may be performed when adequate retinal visualization is achieved.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 20 to 70 years.
* Type 1 or Type 2 diabetes mellitus.
* Diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy.
* Treatment-naïve diabetic vitreous hemorrhage or recurrent/residual vitreous hemorrhage following previous panretinal photocoagulation.
* Phakic or pseudophakic eyes.
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Significant tractional retinal detachment or retinal traction requiring immediate surgery.
* Previous ocular surgery other than cataract surgery.
* Previous intravitreal pharmacologic treatment within the preceding 6 months.
* Any type of glaucoma.
* Active ocular infection or significant ocular surface disease.
* No light perception vision.
* Known hypersensitivity to ranibizumab or any component of the study medication.
* Refusal or inability to provide informed consent.
Source: ClinicalTrials.gov (NCT07690800). StuddyBuddy aggregates publicly available trial information.