NCT02033018

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

December 31, 2013

Last Update Submit

January 9, 2014

Conditions

Choroidal Retinal Neovascularization

Keywords

AfliberceptMyopiaComplicationsNeovascularizationOCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (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.

Study Arms (1)

Aflibercept injection

EXPERIMENTAL

Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection

Drug: Aflibercept Injection

Interventions

Aflibercept InjectionDRUG

Aflibercept intravitreal injection

Also known as: Aflibercept intravitreal injection of 0,5 mg ( 0.05mL
Aflibercept injection

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myopic and CNVM

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto de Olhos de Goiania

Goiânia, Goiás, 74120-050, Brazil

ACTIVE NOT RECRUITING

Instituto de Olhos de Goiania

Goiânia, Goiás, 74120-050, Brazil

RECRUITING

MeSH Terms

Conditions

MyopiaNeovascularization, Pathologic

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joao J Nassaralla, Jr

    Instituto de Olhos de Goiânia

    STUDY CHAIR

Central Study Contacts

Raquel Monteiro

CONTACT

55 62 3220 2500

João J Nassaralla, Jr

CONTACT

55 62 3220 2545nassaral@terra.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 10, 2014

Study Start

October 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

BR(2)