Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
Overview
- Phase
- Phase 4
- Intervention
- Aflibercept Injection
- Conditions
- Choroidal Retinal Neovascularization
- Sponsor
- Instituto de Olhos de Goiania
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Efficacy
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary
Detailed Description
Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. 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. IVTs 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 6 months
Investigators
Eligibility Criteria
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.
Arms & Interventions
Aflibercept injection
Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection
Intervention: Aflibercept Injection
Outcomes
Primary Outcomes
Efficacy
Time Frame: 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.
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.
Secondary Outcomes
- Safety and Tolerability(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.)