Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
Conditions
Keywords
non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept
Brief summary
this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old
Detailed description
This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study. Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\\0.1ml. the second group will receive intravitreal injection of 2.0 mg\\0.1 ml Aflibercept. All patients will be followed up for 12 months.
Interventions
intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)
PROCEDUREintravitreal injection of Aflipercept
intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)
DRUGRanibizumab
Ranibizumab
DRUGAflibercept
Aflipercept
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months. Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs
Eligibility
Sex/Gender
ALL
Age
No minimum to 50 Years
Healthy volunteers
No
Inclusion criteria
* patients younger than 50 years with macular edema due to non-ischemic CRVO
Exclusion criteria
Other conditions that might affect the macula as 1. diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy, 2. patients with ischemic type CRVO and patients who had recent intraocular surgery. 3. patients who had previous intravitreal injections, ophthalmic laser surgeries. 4. patients with dense cataracts whom fundus was difficult to scan. 5. Patients who were lost to follow up visits were also excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity BCVA | at 12 months post-injection | change BCVA after injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of macular edema | at 12 months post-injection | change in central subfield macular thickness CST on OCT |
Countries
Egypt
Outcome results
None listed