Resistant Cystoid Macular EdemaPhase 1NCT00371111
To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema
A Phase 1 study testing Intravitreal injection of Triamcinolone and Intravitreal injection of Avastin in people with Resistant Cystoid Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resistant Cystoid Macular Edema
- What is being tested?
- Intravitreal injection of Triamcinolone and Intravitreal injection of Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2006to Sep 2008
- Phase
- Phase 1
- 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
- Uveitic CME
- Uveitic CME refractory to routine treatment
- Vision better than 5/200 and worse than 20/50
Who cannot join
- Mono- Ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- History of other retinal disease that can cause macular edema
- Pregnancy
- Significant media opacity
- Vision better than 20/50
Trial locations and contacts
1 site in 1 country.
About this study
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
Read the detailed description
This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
- Conditions
- Resistant Cystoid Macular Edema
- Being tested
- Intravitreal injection of Triamcinolone, Intravitreal injection of Avastin
- Keywords
- Resistant uveitic cystoid macular edema, intravitreal triamcinolone, intravitreal bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of TriamcinoloneDrug
4 mg of Triamcinolone
Intravitreal injection of AvastinDrug
Injection of 1.25 mg of Avastin and
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intravitreal injection of Triamcinolone Receives: Drug: Intravitreal injection of Triamcinolone |
| 2 | Active comparator | Intravitreal injection of Avastin Receives: Drug: Intravitreal injection of Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resorbed CME in OCT
Measured: every 3 month
Resorbed CME in clinical examination
Measured: Every 3 month
Secondary outcomes (1)
need to retreatment
Measured: when ever needed
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 startAug 2006
- Primary completionMay 2008
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant Cystoid Macular EdemaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Masoud Soheilian, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371111
- Sponsor's protocol ID
- 8524
- Status last verified
- Jul 2008
- First submitted
- 31 Aug 2006
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT00371111
- Acronym / sponsor ID
- 8524
- Conditions
- Resistant Cystoid Macular Edema
- Keywords
- Resistant uveitic cystoid macular edema, intravitreal triamcinolone, intravitreal bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (estimated)
- 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.
Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
Detailed description
This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Intravitreal injection of TriamcinoloneIntravitreal injection of Triamcinolone |
| 2 | Active comparator | Drug: Intravitreal injection of AvastinIntravitreal injection of Avastin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Uveitic CME
- Uveitic CME refractory to routine treatment
- Vision better than 5/200 and worse than 20/50
Key exclusion criteria (7 listed)
- Mono- Ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- History of other retinal disease that can cause macular edema
- Pregnancy
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 |
|---|---|---|
| Intravitreal injection of Triamcinolone4 mg of Triamcinolone | Drug | 1 |
| Intravitreal injection of AvastinInjection of 1.25 mg of Avastin and | Drug | 2 |
Primary outcome
Resorbed CME in OCT
Time frame: every 3 month
Resorbed CME in clinical examination
Time frame: Every 3 month
1 secondary outcome
need to retreatment
Time frame: when ever needed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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.
Masoud Soheilian, 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 1 study testing Intravitreal injection of Triamcinolone and Intravitreal injection of Avastin in people with Resistant Cystoid Macular Edema, 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 3 inclusion and 7 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 30 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Resorbed CME in OCT (time frame: every 3 month). 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 30 Jul 2008.