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CompletedNCT00776763KIA-ProRetUpdated Jul 22, 2011

Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab

A Phase 2 interventional study of Avastin intravitreal injection in Proliferative Diabetic Retinopathy and Age Related Macular Degeneration, sponsored by Ophthalmological Association Edelweiss. Completed at 1 site in Romania. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.

Sponsored by Ophthalmological Association Edelweiss · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Proliferative Diabetic Retinopathy
  • Age Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 150 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Ophthalmological Association Edelweiss is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Avastin

    Drug: Avastin intravitreal injection

Interventions

  • DrugAvastin intravitreal injection

    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)

06

What researchers measure

Primary outcomes

  1. Growth Factors and Other Cytokines Measurements

    Time frame: 1 month interval

07

Study locations

1 site
  • Railway Universitary Hospital
    Iasi, 700506, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00776763
Lead sponsor
Ophthalmological Association Edelweiss
Collaborators
University of Cologne
First posted
Oct 21, 2008
Start date
Oct 2008
Primary completion
Oct 2009
Completion
Dec 2010
Last update
Jul 22, 2011

Study contacts

NARCISA IANOPOL, Researcher
principal investigator · Railway Universitary Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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