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| ID | Type | Description | Link |
|---|---|---|---|
| B-1207-162-005 | Other Identifier | Seoul National University Bundang Hospital |
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insufficient enrollment
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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Novartis | INDUSTRY |
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The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.
Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab group | Experimental | Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed. |
|
| Standard of care group | Sham Comparator | Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline ETDRS letter score over time | 6 months and 1 year | |
| Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA | 6 months and 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Hyung Park, M.D. | Seoul National Univeristy Bundang Hospital | Principal Investigator |
| Se Woong Kang, M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Gyunggi-do | 463-707 | South Korea | ||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20398941 | Background | Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15. |
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| 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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| Sham injection | Device | Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit |
|
| Rescue laser | Procedure | In the Lucentis group: performed if BCVA < 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA < 20/40 or CFT ≥ 350um from Month 3 |
|
| Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA |
| 6 months and 1 year |
| Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA | 6 months and 1 year |
| Proportion of patients with who at least maintain baseline BCVA | 6 months and 1 year |
| Percentage of patients with central foveal thickness (CFT) of < 300 um | 6 months and 1 year |
| Safety outcomes | Frequency, type, and severity of adverse reactions | 6 months and 1 year |
| Mean change from baseline CFT over time | 6 months and 1 year |
| Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score | 6 months and 1 year |
| Mean change from baseline in contrast sensitivity | 6 months and 1 year |
| Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude | 6 months and 1 year |
| Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA | 6 months and 1 year |
| Seoul |
| 135-710 |
| South Korea |
| 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 |