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Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

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Instituto de Olhos de Goiania

关键词

抽象

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary

描述

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

日期

最后验证: 12/31/2013
首次提交: 12/30/2013
提交的预估入学人数: 01/08/2014
首次发布: 01/09/2014
上次提交的更新: 01/08/2014
最近更新发布: 01/09/2014
实际学习开始日期: 09/30/2013
预计主要完成日期: 10/31/2014
预计完成日期: 10/31/2014

状况或疾病

Choroidal Retinal Neovascularization

干预/治疗

Drug: Aflibercept injection

相 4

手臂组

干预/治疗
Experimental: Aflibercept injection
Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection
Drug: Aflibercept injection
Aflibercept intravitreal injection

资格标准

有资格学习的年龄 21 Years 至 21 Years
有资格学习的性别All
接受健康志愿者
标准

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.

结果

主要结果指标

1. Efficacy [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.

次要成果指标

1. 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.]

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.

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