Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA -CT 2008-005789-30 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that suffer from it has motivated the search for new therapeutic approaches.
In recent times, intravitreal bevacizumab has been tested in clinical practice in small series of patients with this pathology, whether as first treatment or after failure of grid laser treatment with good functional results in short series.
However, no retreatment information is available, although preliminary results from published series are good.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central RVO - Macular edema - Avastin | Experimental | Patients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. |
|
| Central RVO - Macular edema - Sham | Sham Comparator | Patients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. |
|
| Branch RVO - Macular edema - Avastin | Experimental | Patients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol. |
|
| Branch RVO - Macular edema - Sham | Sham Comparator | Patients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin Intravitreal Injection | Drug | Intravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Macular Subcentral Field Thickness assessed by Ocular coherence tomography | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| María Isabel López Gálvez, MD, PhD | IOBA - Instituto Universitario de Oftalmobiología Aplicada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Oftalmológico de Alicante | Alicante | Alicante | 03015 | Spain | ||
| Hospital de la Vall D´Hebrón |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Avastin Intravitreal Injection | Drug | Intravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...). |
|
|
| Barcelona |
| Barcelona |
| 08022 |
| Spain |
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| Hospital Provincial Conxo - Fundación IDICHUS | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28010 | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital General Reina Sofía | Espinardo | Murcia | 30100 | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31080 | Spain |
| Hospital Virgen de la Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Virgen de Valme | Seville | Sevilla | 41014 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Instituto Universitario de Oftalmobiología Aplicada | Valladolid | Valladolid | 47011 | Spain |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided