Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization (AflibxMyopia)

Instituto de Olhos de Goiania

Status and phase: Unknown; Phase 4

Conditions: Choroidal Retinal Neovascularization

Treatments: Drug: Aflibercept Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02033018

JJ - 3/2013

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Aflibercept injection

Experimental group

Description:

Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection

Treatment:

Drug: Aflibercept Injection