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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04460001
Other study ID # WAMohamed
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 16, 2019
Est. completion date December 1, 2021

Study information

Verified date November 2019
Source Assiut University
Contact Wael Ismael
Phone 01006322380
Email wael.ali.ismael@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ranibizumab
Intravitreal
Ranibizumab
Intravitreal
triamcinolone acetate
intravitreal

Locations

Country Name City State
Egypt Wael Asyut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO 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.
2 year
Primary Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO 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).
2 year
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