Clinical trial NCT00776763: Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
Official title: The Profile of the Growth Factors and Other Mediators of Angiogenesis in the Ocular Fluids in Proliferative Retinopathies (AMD and PDR) Before and After the Intravitreal Administration of Bevacizumab (Avastin) as an Anti-VEGF Blocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proliferative Diabetic Retinopathy
Age Related Macular Degeneration
Lead sponsor: Ophthalmological Association Edelweiss
Sponsor class: OTHER
Collaborators: name: University of Cologne
First posted: 2008-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Growth Factors and Other Cytokines Measurements
timeFrame: 1 month interval
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Railway Universitary Hospital
Study officials:
affiliation: Railway Universitary Hospital
name: NARCISA IANOPOL, Researcher
role: PRINCIPAL_INVESTIGATOR
References: