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Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization (AflibxMyopia)

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ClinicalTrials.gov Identifier: NCT02033018
Recruitment Status : Unknown
Verified January 2014 by Instituto de Olhos de Goiania.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto de Olhos de Goiania

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

Condition or disease Intervention/treatment Phase
Choroidal Retinal Neovascularization Drug: Aflibercept Injection Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
Study Start Date : October 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

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Arm Intervention/treatment
Experimental: Aflibercept injection
Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection
Drug: Aflibercept Injection
Aflibercept intravitreal injection
Other Name: Aflibercept intravitreal injection of 0,5 mg ( 0.05mL




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Safety and Tolerability [ 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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033018


Contacts
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Contact: Raquel Monteiro 55 62 3220 2500
Contact: João J Nassaralla, Jr 55 62 3220 2545 nassaral@terra.com.br

Locations
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Brazil
Instituto de Olhos de Goiania Active, not recruiting
Goiania, GO, Brazil, 74120-050
Instituto de Olhos de Goiania Recruiting
Goiania, GO, Brazil, 74120-050
Contact: Raquel Monteiro    55 62 3220 2511      
Contact: João J Nassaralla, JR    55 62 3220 2545    nassaral@terra.com.br   
Principal Investigator: Joao J Nassaralla, Jr         
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
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Study Chair: Joao J Nassaralla, Jr Instituto de Olhos de Goiânia

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Responsible Party: Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT02033018     History of Changes
Other Study ID Numbers: JJ - 3/2013
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Instituto de Olhos de Goiania:
Aflibercept
Myopia
Complications
Neovascularization
OCT
Additional relevant MeSH terms:
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Choroidal Neovascularization
Retinal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Diseases