Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization (AflibxMyopia)

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

Study Overview

• Status: Unknown
• Conditions: Choroidal Retinal Neovascularization
• Intervention / Treatment: Drug: Aflibercept Injection

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raquel Monteiro; Phone Number: 55 62 3220 2500
• Study Contact Backup: Name: João J Nassaralla, JR; Phone Number: 55 62 3220 2545; Email: nassaral@terra.com.br

Study Locations

• Brazil
  • GO
    • Goiania, GO, Brazil, 74120-050
      • Active, not recruiting
      • Instituto de Olhos de Goiania
    • Goiania, GO, Brazil, 74120-050
      • Recruiting
      • Instituto de Olhos de Goiania
      • Contact: João J Nassaralla, JR; Phone Number: 55 62 3220 2545; Email: nassaral@terra.com.br
      • Contact: Raquel Monteiro; Phone Number: 55 62 3220 2511
      • Principal Investigator: Joao J Nassaralla, Jr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept injection; Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection	Drug: Aflibercept Injection; Aflibercept intravitreal injection; Other Names: Aflibercept intravitreal injection of 0,5 mg ( 0.05mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Instituto de Olhos de Goiania
• Investigators: Study Chair: Joao J Nassaralla, Jr, Instituto de Olhos de Goiania

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: OCT; Complications; Aflibercept; Myopia; Neovascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Retinal Neovascularization; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: JJ - 3/2013