Choroidal Retinal Neovascularization Clinical Trial
— AflibxMyopiaOfficial title:
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Myopic and CNVM Exclusion Criteria: - Patients with poor compliance - Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients). - Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved. - Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery. - Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods. - Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR. - Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Instituto de Olhos de Goiania | Goiania | GO |
| Brazil | Instituto de Olhos de Goiania | Goiania | GO |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Olhos de Goiania |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | 8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. AII were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 1 year. | To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up. | Yes |
| Secondary | Safety and Tolerability | 8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. | To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up. | Yes |