Central Retinal Vein Occlusion
Conditions
Brief summary
Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number of needed injections over a 18 month period in patients with newly diagnosed CRVO.
Detailed description
Forty patients diagnosed with a new central retinal vein occlusion (CRVO) of a maximum duration of 6 months will be recruited to the study. Patients will be randomized 1:1 to treatment with aflibercept ot ranibizumab. all patients will receive 3 initial monthly injections. There after injections will be given att every visit according to a treat and extend schedule. If no macular edema is seen on the Ocular coherent tomography (OCT) examination the next treatment will be after 6 weeks. If the macula is dry after 6 weeks a new injection is given and the next visit is scheduled for another 8 weeks. If edema is seen on the OCT after 8 weeks the time to next injection is reduced to 6 weeks. Patients cannot receive an injection more often than every 4 weeks. All patients will receive an injection at least every 12 weeks. Primary outcome: the number of needed injections over a 18 month period comparing ranibizumab and aflibercept. Secondary outcome: Change in visual acuity, change in macular thickness. A subgroup of patients will also be evaluated with OCT angiography. A possible relationship between the Visual acuity and the foveal avascular zone will be evaluated.
Interventions
DRUGAflibercept
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
DRUGRanibizumab
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Sponsors
Anders Kvanta
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 No maximum
Healthy volunteers
No
Inclusion criteria
* CRVO - naive patients, disease duration maximum 12 months, Best corrected visual acuity : 23-73 letters (20/40 - 20/320), Macular edema \> 300 μm (Cirrus)
Exclusion criteria
* Neovascular Glaucoma Any previous treatment for CRVO. Intraocular surgery during the previous 3 months. Vascular retinopathy of other causes. Glaucoma with uncontrolled IOP (intra ocular pressure) Myocardial infarction or stroke during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of needed injections over a 18 month period comparing ranibizumab and aflibercept. | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity | 18 months | Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters |
| Change in macular thickness | 18 months | Change in macular thickness measured by Cirrus OCT (µm) |
Countries
Sweden
Outcome results
None listed