NCT00776763

Brief Summary

Aims of the trial: Establishing the profile of the growth factors and other mediators of angiogenesis in different ocular fluids (aqueous humour, vitreous gel and ocular liquid in vitrectomized eyes), in the 2 most frequent proliferative retinopathies - diabetic proliferative retinopathy (PDR) and exudative age related macular degeneration (AMD). Following up the dynamic of this profile before and after intravitreal administration of Bevacizumab (Avastin) as an anti-VEGF blocker. Materials: The research will be conducted on the following categories of patients groups:

  • nondiabetic patients without AMD or any other diagnosed proliferative ocular disease (controls)
  • patients with age related macular degeneration (AMD groups) before and after intravitreal injections with Avastin
  • diabetic patients with different types of diabetic retinopathy, before and after intravitreal Avastin (diabetic groups) Methods: Samples from different ocular fluids will be collected from each group of patients. 10 growth factors and other 10 cytokines will be determined in the ocular fluids samples. Results: The results from the biochemical measurements will be statistically interpreted in order to obtain conclusions for the clinical practice. Conclusions: The conclusions of this trial will be used exclusively for research publications and communications, as well as for clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 22, 2011

Status Verified

October 1, 2008

Enrollment Period

1 year

First QC Date

October 17, 2008

Last Update Submit

July 20, 2011

Conditions

Proliferative Diabetic RetinopathyAge Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Growth Factors and Other Cytokines Measurements

    1 month interval

Study Arms (1)

Avastin

EXPERIMENTAL
Drug: Avastin intravitreal injection

Interventions

Avastin intravitreal injectionDRUG

1,25 mg of Bevacizumab (Avastin) will be intravitreally injected 4 weeks interval in the proliferative retinopathies groups (exudative age related macular degeneration and proliferative diabetic retinopathy)

Avastin

Eligibility Criteria

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

You may qualify if:

  • age over 20 years
  • nondiabetic patients requiring cataract surgery or vitrectomy for different posterior segment nonproliferative disorders - controls groups
  • diabetic patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - diabetic groups
  • diabetic patients requiring cataract surgery or vitrectomy - diabetic groups
  • age related macular degeneration patients asking ophthalmologic treatments for different degrees of decreasing of visual acuity - age related macular degeneration groups
  • age related macular degeneration patients requiring cataract surgery or vitrectomy - age related macular degeneration groups

You may not qualify if:

  • patients under the age of 20 years
  • patients that did not accept and signed the informed consent of the trial
  • patients that received any anti-VEGF therapy for any proliferative or inflammatory ocular disease
  • patients that received any type of intraocular injection with any pharmaceutical agent
  • patients with any clinical type of malignancy in their pathologic antecedents
  • patients with recent penetrating trauma (less than 1 year old)
  • patients operated for different ocular disorders requiring combination with antimetabolites (ex. 5-FU or Mitomycin C with trabeculectomy)
  • patients with intraocular inflammations or infections or other pathologies that contraindicate open globe surgery or intraocular injections with anti-VEGF blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway Universitary Hospital

Iași, 700506, Romania

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • NARCISA IANOPOL, Researcher

    Railway Universitary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 21, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2010

Last Updated

July 22, 2011

Record last verified: 2008-10

Locations

RO(1)