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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC |
|
| Treatment Group | Experimental | Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug |
|
| |
| micropulse diode laser |
| Measure | Description | Time Frame |
|---|---|---|
| change in best corrected visual acuity (BCVA) | baseline, 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| change in central macular thickness | baseline, 12 month | |
| number of intravitreal Lucentis injections | within 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klio Ai Becker, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32727496 | Derived | Furashova O, Strassburger P, Becker KA, Engelmann K. Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial. BMC Ophthalmol. 2020 Jul 29;20(1):308. doi: 10.1186/s12886-020-01576-w. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2018 | |
| Reset | Oct 25, 2018 | |
| Release | Apr 25, 2022 | |
| Reset | Jan 25, 2023 | |
| Release | Jan 26, 2023 | |
| Reset | Nov 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2018 | Oct 25, 2018 | |||
| Apr 25, 2022 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Procedure |
|
| Jan 25, 2023 |
| Jan 26, 2023 | Nov 7, 2023 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |