NCT00797992

Brief Summary

To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
Last Updated

November 25, 2008

Status Verified

November 1, 2008

Enrollment Period

1.8 years

First QC Date

November 24, 2008

Last Update Submit

November 24, 2008

Conditions

Myopic Choroidal Neovascularization

Keywords

BevacizumabMyopiaComplicationsNeovascularizationOCT

Study Arms (1)

1

EXPERIMENTAL

Myopic eyes with retinal neovascularization

Drug: Injection

Interventions

InjectionDRUG

Intravitreal injection of 1.25 mg bevacizumab

1

Eligibility Criteria

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

You may qualify if:

  • Myopic 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

Injections

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Joao J Nassaralla, PhD

    Instituto de Olhos de Goiania

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 25, 2008

Record last verified: 2008-11

Locations

BR(1)