Ophthalmopathy
Conditions
Brief summary
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO
Interventions
DRUGRanibizumab
Intravitreal
intravitreal
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactWael Ismael
Outcome results
None listed