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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04460001

Collaborator

(none)

100

Enrollment

Location

Arms

30.6

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ophthalmopathy	Drug: Ranibizumab Drug: Ranibizumab Drug: triamcinolone acetate	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

Actual Study Start Date :

May 16, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ranibizumab intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up	Drug: Ranibizumab Intravitreal
Active Comparator: 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	Drug: Ranibizumab Intravitreal Drug: triamcinolone acetate intravitreal

Arm

Intervention/Treatment

Active Comparator: Ranibizumab

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

Drug: Ranibizumab

Intravitreal

Active Comparator: 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

Drug: Ranibizumab

Intravitreal

Drug: triamcinolone acetate

intravitreal

Outcome Measures

Primary Outcome Measures

Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO [2 year]
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Best-Corrected Visual Acuity: will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO [2 year]
To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Optical Coherence Tomography: will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wael	Asyut		Egypt	11711

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wael Ali Mohamed, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04460001

Other Study ID Numbers:

WAMohamed

First Posted:

Jul 7, 2020

Last Update Posted:

Jul 7, 2020

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Eye Diseases

Triamcinolone

Ranibizumab

Study Results

No Results Posted as of Jul 7, 2020