Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ophthalmopathy

Treatments: Drug: triamcinolone acetate; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04460001

WAMohamed

Details and patient eligibility

About

To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
• A BCVA approximate Snellen equivalents, 20/40.

Exclusion criteria

• Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
• Pan-retinal laser photocoagulation 3 months or less before baseline,
• Topical ocular or systemic corticosteroids administered for 30 consecutive days.
• Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
• Use of intraocular corticosteroid implants,
• Uncontrolled glaucoma (intraocular pressure [IOP] 30 mmHg with medication) at the time of screening or baseline,
• iris neovascularization or neo-vascular glaucoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Ranibizumab

Active Comparator group

Description:

intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Ranibizumab and triamcinolone acetate

Active Comparator group

Description:

intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up

Treatment:

Drug: Ranibizumab

Drug: triamcinolone acetate

Drug: Ranibizumab