Macular EdemaPhase 2SURFINGNCT00846625
Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids
A Phase 2 study testing triamcinolone and ranibizumab in people with Macular Edema and Uveitis, run by University of Utah at 1 site in United States.
Trial summary
This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Uveitis
- What is being tested?
- triamcinolone and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- History of non-infectious uveitis w chronic cystoid macular edema
- Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment
- Currently using oral steroids (< or = 10 mg/day) and/or steroid sparing agents
- BCVA between 20/40 and 20/400
- IOP between 5 mmHg and 30 mmHg
- Media clarity sufficient for OCT measurement
Who cannot join
- Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study
- Prior treatment for CME with Macugen or Avastin in the study eye
- History of stroke
- Presence of vitreous hemorrhage or epiretinal membrane in the study eye
- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
- Presence or history of uncontrolled glaucoma
Show all 9Show fewer
- Known allergy or hypersensitivity to any component of the study drug
- Major surgery planned during the next 6 months
- Simultaneous participation in another clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids Following a Periocular Steroid Injections in Patients on Steroid Sparing Agents or Low Dose Steroids
This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.
Read the detailed description
This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.
- Conditions
- Macular Edema, Uveitis
- Being tested
- triamcinolone, ranibizumab
- Keywords
- Biomedical research, Macular Edema, Uveitis, Ranibizumab, Steroids
- Medical subject headings
- Macular Edema, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinoloneDrug
Also called Triescence
Intravitreal injection (4 mg/0.1 ml)
ranibizumabDrug
Also called Lucentis
Intravitreal injection, 0.5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ranibizumab (0.5 mg) Receives: Drug: ranibizumab |
| 2 | Active comparator | Triamcinolone (4 mg/0.1 ml) Receives: Drug: triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular adverse events
Measured: 12 months
Secondary outcomes (1)
Resolution of macular edema by OCT measurement
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Insufficient enrollment (no subjects were enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Albert T Vitale, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846625
- Sponsor's protocol ID
- 34035
- Acronym
- SURFING
- Status last verified
- Dec 2014
- First submitted
- 18 Feb 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids Following a Periocular Steroid Injections in Patients on Steroid Sparing Agents or Low Dose Steroids
- ClinicalTrials.gov ID
- NCT00846625
- Acronym / sponsor ID
- SURFING / 34035
- Conditions
- Macular Edema, Uveitis
- Keywords
- Biomedical research, Macular Edema, Uveitis, Ranibizumab, Steroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment (no subjects were enrolled)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Feb 2009 (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.
This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-infectious uveitis. There is currently no FDA-approved therapy for this condition, however intravitreal injection of corticosteroids, in conjunction with oral steroids and/or immunomodulatory drug agents, has become the mainstay of therapy. Ranibizumab is a recombinant monoclonal antibody antigen-binding fragment that neutralizes the active forms of vascular endothelial growth factor (VEGF), which is believed to contribute to the etiology of inflammation and neovascularization. Ranibizumab is FDA-approved for the treatment of neovascular age-related macular degeneration.
Detailed description
This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections of steroids in patients with uveitic macular edema, only patients who are refractory to periocular steroids will be enrolled in the study. The 0.5 mg dose of ranibizumab will be given intravitreally since this dose and route has been found to be safe and efficacious in prior studies. A dosing regimen has not been established for ranibizumab in patients with uveitis, so patients will be assessed and treated monthly as needed. Triamcinolone 4mg intravitreal injection will be the steroid treatment, and patients will also be assessed monthly and retreated every three months as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ranibizumabRanibizumab (0.5 mg) |
| 2 | Active comparator | Drug: triamcinoloneTriamcinolone (4 mg/0.1 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- History of non-infectious uveitis w chronic cystoid macular edema
- Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment
- Currently using oral steroids (< or = 10 mg/day) and/or steroid sparing agents
- BCVA between 20/40 and 20/400
Key exclusion criteria (9 listed)
- Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study
- Prior treatment for CME with Macugen or Avastin in the study eye
- History of stroke
- Presence of vitreous hemorrhage or epiretinal membrane in the study eye
- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
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 |
|---|---|---|
| triamcinoloneAlso: TriescenceIntravitreal injection (4 mg/0.1 ml) | Drug | 2 |
| ranibizumabAlso: LucentisIntravitreal injection, 0.5 mg | Drug | 1 |
Primary outcome
Ocular adverse events
Time frame: 12 months
1 secondary outcome
Resolution of macular edema by OCT measurement
Time frame: 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Albert T Vitale, MD principal investigator
University of Utah
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 triamcinolone and ranibizumab in people with Macular Edema and Uveitis, run by University of Utah at 1 site in United States.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 Dec 2014. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Ocular adverse events (time frame: 12 months). 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 11 Dec 2014.