Cystoid Macular EdemaPhase 2NCT00114062
Study to Treat Uveitis Associated Macular Edema
A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Cystoid Macular Edema and Uveitis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema, Uveitis
- What is being tested?
- denufosol tetrasodium (INS37217) Intravitreal Injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2006
- 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
- Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- Have persistent macular edema and uveitis whose conditions are stable
- Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
- Have an OCT scan with a qualifying retinal thickness in the study eye
- Have evidence of macular edema on OCT scan
- Have at lease one eligible eye to be treated in the study based on visual acuity.
Who cannot join
- Have proliferative vitreoretinopathy greater than grade B
- Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
- Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
- Have ocular disorders in the study eye that may confound interpretation of study results
- Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye
Show all 9Show fewer
- Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening
- Have any ocular implant device for the delivery of therapeutic agents to the eye
- Be taking any excluded medications that could obscure or confound study results
About this study
Official title: A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema
The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.
Read the detailed description
Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.
- Conditions
- Cystoid Macular Edema, Uveitis
- Being tested
- denufosol tetrasodium (INS37217) Intravitreal Injection
- Keywords
- uveitis, macular edema, uveitis associated macular edema
- 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.
denufosol tetrasodium (INS37217) Intravitreal InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
Assess the utility of denufosol in treating uveitis associated macular edema.
Secondary outcomes (1)
Pilot study - not specified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular EdemaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Double blind
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Schaberg, BSN, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114062
- Sponsor's protocol ID
- 06-103
- Status last verified
- Nov 2016
- First submitted
- 13 Jun 2005
- Last updated
- 29 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema
- ClinicalTrials.gov ID
- NCT00114062
- Acronym / sponsor ID
- 06-103
- Conditions
- Cystoid Macular Edema, Uveitis
- Keywords
- uveitis, macular edema, uveitis associated macular edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Jun 2005 (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 purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.
Detailed description
Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- Have persistent macular edema and uveitis whose conditions are stable
- Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
- Have an OCT scan with a qualifying retinal thickness in the study eye
- Have evidence of macular edema on OCT scan
Key exclusion criteria (9 listed)
- Have proliferative vitreoretinopathy greater than grade B
- Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
- Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
- Have ocular disorders in the study eye that may confound interpretation of study results
- Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
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 |
|---|---|---|
| denufosol tetrasodium (INS37217) Intravitreal Injection | Drug | – |
Primary outcome
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
Assess the utility of denufosol in treating uveitis associated macular edema.
1 secondary outcome
Pilot study - not specified
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
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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.
Amy Schaberg, BSN study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Cystoid Macular Edema and Uveitis, run by Merck Sharp & Dohme LLC.
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 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: stopped early, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early. 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?
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.. 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 29 Nov 2016.