A Phase 4 interventional study of Aflibercept Injection [Eylea] and Ranibizumab Injection [Lucentis] in Branch Retinal Vein Occlusion with Macular Edema, sponsored by St. Erik Eye Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by St. Erik Eye Hospital · Phase 4, Interventional, and Treatment
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.
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.
St. Erik Eye Hospital is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Aflibercept is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen.
Drug: Aflibercept Injection [Eylea]
Ranibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen.
Drug: Ranibizumab Injection [Lucentis]
Intravitreal injection is given as described in the arm description
Also known as: Eylea
Intravitreal injection is given as described in the arm description
Also known as: Lucentis
Difference in time to recurrence of macular edema
Time, in weeks, from completion of loading dose to first recurrence of macular edema.
Time frame: 9 months
Comparison of the number of patients without ME in each treatment arm at one month after the first injection
The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared
Time frame: 1 month
Comparison of the number of injections needed in each treatment arm to resolve ME
The number of injections needed for macular edema to resolve in each treatment arm are compared
Time frame: 9 months
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aflibercept · Ranibizumab
St. Erik Eye Hospital