Proliferative Diabetic RetinopathyPhase 2KIA-ProRetNCT00776763
Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab
A Phase 2 study testing Avastin intravitreal injection in people with Proliferative Diabetic Retinopathy and Age Related Macular Degeneration, run by Ophthalmological Association Edelweiss at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Age Related Macular Degeneration
- What is being tested?
- Avastin intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
- Being tested
- Avastin intravitreal injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Experimental | Not described Receives: Drug: Avastin intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Factors and Other Cytokines Measurements
Measured: 1 month interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmological Association Edelweiss
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne
- Investigators
- NARCISA IANOPOL, Researcher, Principal investigator, Railway Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776763
- Sponsor's protocol ID
- KIA-ProRet
- Acronym
- KIA-ProRet
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00776763
- Acronym / sponsor ID
- KIA-ProRet / KIA-ProRet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ophthalmological Association EdelweissUniversity, hospital or other
- Collaborators
- University of Cologne
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin | Experimental | Drug: Avastin intravitreal injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin intravitreal injection1,25 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) | Drug | Avastin |
Primary outcome
Growth Factors and Other Cytokines Measurements
Time frame: 1 month interval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NARCISA IANOPOL, Researcher principal investigator
Railway Universitary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin intravitreal injection in people with Proliferative Diabetic Retinopathy and Age Related Macular Degeneration, run by Ophthalmological Association Edelweiss at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth Factors and Other Cytokines Measurements (time frame: 1 month interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.