St Eriks Eye Hospital
Stockholm, Stockholm County, 11282, Sweden
NCT Number: NCT03709745
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Stockholm, Stockholm County, 11282, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal injection is given as described in the arm description
Other names: Eylea
Intravitreal injection is given as described in the arm description
Other names: Lucentis
Time frame: 9 months
Time, in weeks, from completion of loading dose to first recurrence of macular edema.
Time frame: 1 month
The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared
Time frame: 9 months
The number of injections needed for macular edema to resolve in each treatment arm are compared
Time frame: 9 months
St. Erik Eye Hospital
Other
A Randomized Trial Comparing Treatment with Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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