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Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02033018
Acronym
AflibxMyopia
Enrollment
20
Registered
2014-01-10
Start date
2013-10-31
Completion date
2014-11-30
Last updated
2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Retinal Neovascularization

Keywords

Aflibercept, Myopia, Complications, Neovascularization, OCT

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

Interventions

Aflibercept intravitreal injection

Sponsors

Instituto de Olhos de Goiania
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
EfficacyTo 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

MeasureTime frameDescription
Safety and TolerabilityTo 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.

Countries

Brazil

Contacts

Primary ContactRaquel Monteiro
55 62 3220 2500
Backup ContactJoão J Nassaralla, Jr
nassaral@terra.com.br55 62 3220 2545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026