Retinal NeovascularizationPhase 2SITE-AppNCT00564148
Intravitreal Avastin in Proliferative Retinopathies
A Phase 2 study testing Avastin in people with Retinal Neovascularization, run by Ophthalmological Association Edelweiss at 1 site in Romania.
Trial summary
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Retinal Neovascularization
- What is being tested?
- Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- Jul 2007to Dec 2009
- 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
- clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
- distance acuity < 0.5
- age > 20 years
Who cannot join
- noncooperative patients
- ocular infections / inflammations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes
Read the detailed description
Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.
Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.
- Conditions
- Retinal Neovascularization
- Being tested
- Avastin
- Keywords
- antiVEGF therapy
- Medical subject headings
- Retinal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called Bevacizumab
2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively
| Study group | Role | What they receive |
|---|---|---|
| A,1, II | Experimental | Not described Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus
Measured: one year
Secondary outcomes (1)
The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal NeovascularizationStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmological Association Edelweiss
- Sponsor type
- University, hospital or other
- Investigators
- NARCISA IANOPOL, researcher, Principal investigator, Ophthalmological Association Edelweiss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564148
- Sponsor's protocol ID
- AVAST-ro-1
- Other IDs
- SITE-App
- Acronym
- SITE-App
- Status last verified
- Jun 2008
- First submitted
- 26 Nov 2007
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- 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
- Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
- ClinicalTrials.gov ID
- NCT00564148
- Acronym / sponsor ID
- SITE-App / AVAST-ro-1
- Conditions
- Retinal Neovascularization
- Keywords
- antiVEGF therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ophthalmological Association EdelweissUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Nov 2007 (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.
The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes
Detailed description
Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.
Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1, II | Experimental | Drug: Avastin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
- distance acuity < 0.5
- age > 20 years
Key exclusion criteria (2 listed)
- noncooperative patients
- ocular infections / inflammations
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 |
|---|---|---|
| AvastinAlso: Bevacizumab2,5 mg Avastin intravitreal injections every 4 weeks, 6 months consecutively | Drug | A,1, II |
Primary outcome
The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus
Time frame: one year
1 secondary outcome
The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections
Time frame: one year
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
Ophthalmological Association Edelweiss
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 in people with Retinal Neovascularization, 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 3 inclusion and 2 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?
The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus (time frame: one year). 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; AzTrials last refreshed its copy on 3 Nov 2026.