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The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).
In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT guided group | Experimental | Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT. |
|
| Standard treatment | Active Comparator | Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | comparison of different re-treatment criteria for intravitreal injection of ranibizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of best corrected visual acuity (BCVA) measured in ETDRS letters | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central retinal thickness (CRT) | 12 months | |
| Number of applied ranibizumab injections | 12 months | |
| • Rates of patients developing a neovascularisation of the retina/ anterior segment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matus Rehak, MD, Ph.D. | Department of Ophthalmology, University of Leipzig, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, University Leipzig | Leipzig | 04103 | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2023 | |
| Reset | Nov 10, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2023 | Nov 10, 2023 |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 12 months |
| Assessment of safety: serious adverse events/ reactions; AEs/ARs | 12 months |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |