- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776763
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab (KIA-ProRet)
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Iasi, Romania, 700506
- Railway Universitary Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Avastin
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Growth Factors and Other Cytokines Measurements
Time Frame: 1 month interval
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1 month interval
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: NARCISA IANOPOL, Researcher, Railway Universitary Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- KIA-ProRet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
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Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
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Charles C Wykoff, PhD, MDRegeneron PharmaceuticalsCompletedProliferative Diabetic RetinopathyUnited States
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Kubota Vision Inc.CompletedProliferative Diabetic RetinopathyUnited States
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