NCT01246089

Brief Summary

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

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 Jul 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

5.3 years

First QC Date

November 20, 2010

Last Update Submit

December 31, 2013

Conditions

Myopic Choroidal Neovascularization

Keywords

RanibizumabMyopiaComplicationsNeovascularizationOCT

Study Arms (1)

Ranabizumab

EXPERIMENTAL

Myopic eyes with retinal neovascularization

Drug: ranibizumab injection

Interventions

ranibizumab injectionDRUG

Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Ranabizumab

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 (1)

Instituto de Olhos de Goiania

Goiânia, Goiás, 74120-050, Brazil

Location

MeSH Terms

Conditions

MyopiaNeovascularization, Pathologic

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 20, 2010

First Posted

November 23, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

BR(1)