Diabetic RetinopathyPhase 3NCT00370721
Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)
A Phase 3 study testing bevacizumab in people with Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Mar 2006to not given
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases of active progressive PDR with history of scatter laser photocoagulation
Who cannot join
- history of vitrectomy
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hamid Ahmadieh, MD
Tehran, Tehran Province, 16666
Hamid Ahmadieh, MD, +98 21 22585952, hahmadieh@hotmail.com
About this study
To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR
- Conditions
- Diabetic Retinopathy
- Being tested
- bevacizumab
- Keywords
- Proliferative diabetic retinopathy(PDR), Pan retinal photocoagulation (PRP), Vitreous hemorrhage, Traction retinal detachment, Neovascularization on disc (NVD), Neovascularization elsewhere (NVE), Fibrous proliferation on disc (FPD), Fibrous proliferaiton elsewhere (FPE)
- Medical subject headings
- Diabetic Retinopathy, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of diabetic retinopathy
visual acuity
Secondary outcomes (5)
neovascularization
fibrous proliferation
traction retinal detachment
vitreous hemorrhage
pan retinal photocoagulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamid Ahmadieh, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370721
- Sponsor's protocol ID
- 8538
- Status last verified
- Jun 2008
- First submitted
- 30 Aug 2006
- Last updated
- 26 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT00370721
- Acronym / sponsor ID
- 8538
- Conditions
- Diabetic Retinopathy
- Keywords
- Proliferative diabetic retinopathy(PDR), Pan retinal photocoagulation (PRP), Vitreous hemorrhage, Traction retinal detachment, Neovascularization on disc (NVD), Neovascularization elsewhere (NVE), Fibrous proliferation on disc (FPD), Fibrous proliferaiton elsewhere (FPE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 1 Sep 2006 (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.
To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: bevacizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases of active progressive PDR with history of scatter laser photocoagulation
Key exclusion criteria (1 listed)
- history of vitrectomy
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 |
|---|---|---|
| bevacizumab | Drug | I |
Primary outcome
Regression of diabetic retinopathy
visual acuity
5 secondary outcomes
neovascularization
fibrous proliferation
traction retinal detachment
vitreous hemorrhage
pan retinal photocoagulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
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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.
Hamid Ahmadieh, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab in people with Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2008. 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 Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamid Ahmadieh, MD (+98 21 22585952, hahmadieh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of diabetic retinopathy. The study lists 2 primary outcomes in all. 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 26 Jun 2008.