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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00776763
Other study ID # KIA-ProRet
Secondary ID
Status Completed
Phase Phase 2
First received October 17, 2008
Last updated July 20, 2011
Start date October 2008
Est. completion date December 2010

Study information

Verified date October 2008
Source Ophthalmological Association Edelweiss
Contact n/a
Is FDA regulated No
Health authority Romania: Ministry of Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Avastin 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)

Locations

Country Name City State
Romania Railway Universitary Hospital Iasi

Sponsors (2)

Lead Sponsor Collaborator
Ophthalmological Association Edelweiss University of Cologne

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth Factors and Other Cytokines Measurements 1 month interval No
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