Branch Retinal Vein Occlusion with Macular Edema
Conditions
Brief summary
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.
Detailed description
One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm. At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.
Interventions
Intravitreal injection is given as described in the arm description
Intravitreal injection is given as described in the arm description
Sponsors
St. Erik Eye Hospital
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
* BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT \> 300 micrometers (Cirrus)
Exclusion criteria
* BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular stroke during the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in time to recurrence of macular edema | 9 months | Time, in weeks, from completion of loading dose to first recurrence of macular edema. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the number of patients without ME in each treatment arm at one month after the first injection | 1 month | The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared |
| Comparison of the number of injections needed in each treatment arm to resolve ME | 9 months | The number of injections needed for macular edema to resolve in each treatment arm are compared |
| Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs. | 9 months | — |
Countries
Sweden
Outcome results
None listed