NCT00564148

Brief Summary

The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 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

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 22, 2011

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

November 26, 2007

Last Update Submit

July 20, 2011

Conditions

Retinal Neovascularization

Keywords

antiVEGF therapy

Outcome Measures

Primary Outcomes (1)

  • The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus

    one year

Secondary Outcomes (1)

  • The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections

    one year

Study Arms (1)

A,1, II

EXPERIMENTAL
Drug: Avastin

Interventions

AvastinDRUG

2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively

Also known as: Bevacizumab
A,1, II

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
  • distance acuity \< 0.5
  • age \> 20 years

You may not qualify if:

  • noncooperative patients
  • ocular infections / inflammations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochiul Diabetic

Iași, 700377, Romania

Location

MeSH Terms

Conditions

Retinal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • NARCISA IANOPOL, researcher

    Ophthalmological Association Edelweiss

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

July 22, 2011

Record last verified: 2008-06

Locations

RO(1)