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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Active Comparator | 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. |
|
| Ranibizumab | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Injection [Eylea] | Drug | Intravitreal injection is given as described in the arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in time to recurrence of macular edema | Time, in weeks, from completion of loading dose to first recurrence of macular edema. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Comparison of the number of injections needed in each treatment arm to resolve ME |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Kvanta, MD PhD | St. Erik Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Eriks Eye Hospital | Stockholm | Stockholm County | 11282 | Sweden |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab Injection [Lucentis] | Drug | Intravitreal injection is given as described in the arm description |
|
|
The number of injections needed for macular edema to resolve in each treatment arm are compared |
| 9 months |
| Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs. | 9 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |