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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-16

Study Completion Date

2021-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ranibizumab

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

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

Intravitreal

Ranibizumab and triamcinolone acetate

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

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

Intravitreal

triamcinolone acetate

Intervention Type DRUG

intravitreal

Interventions

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Ranibizumab

Intravitreal

Intervention Type DRUG

Ranibizumab

Intravitreal

Intervention Type DRUG

triamcinolone acetate

intravitreal

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes