Back to resultsInjection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)
Primary Purpose
Ophthalmopathy
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab
triamcinolone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Ophthalmopathy
Eligibility Criteria
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.
Sites / Locations
- WaelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ranibizumab
Ranibizumab and triamcinolone acetate
Arm Description
intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
Outcomes
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
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
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04460001
Brief Title
Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
Arm Title
Ranibizumab and triamcinolone acetate
Arm Type
Active Comparator
Arm Description
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Intravitreal
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Intravitreal
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetate
Intervention Description
intravitreal
Primary Outcome Measure Information:
Title
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
Description
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.
Time Frame
2 year
Title
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
Description
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).
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wael Ismael
Phone
01006322380
Email
wael.ali.ismael@gmail.com
Facility Information:
Facility Name
Wael
City
Asyut
ZIP/Postal Code
11711
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael Ismael
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)
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