Macular Edema, CystoidPhase 2NCT00135655
A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Macular Edema, Cystoid, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Cystoid
- What is being tested?
- denufosol tetrasodium (INS37217) Intravitreal Injection
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to not given
- 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 persistent post cataract extraction macular edema whose condition is stable
- Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
- Have at least one eligible eye to be treated in the study
- Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
- Have macular edema confirmed by fluorescein angiography
Who cannot join
- Have proliferative vitreoretinopathy greater than grade B in either eye
- Have ocular disorders in the study eye that may confound interpretation of study results
- Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
- Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
- Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
- Have had any ocular implant device for the delivery of therapeutic agents
- 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 Post Cataract Extraction Macular Edema
The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.
- Conditions
- Macular Edema, Cystoid
- Being tested
- denufosol tetrasodium (INS37217) Intravitreal Injection
- Keywords
- macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema
- Medical subject headings
- Macular Edema
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.
safety
tolerability
retinal thickness
visual acuity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema, CystoidStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy Schaberg, BSN, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135655
- Sponsor's protocol ID
- 06-104
- Status last verified
- May 2013
- First submitted
- 24 Aug 2005
- Last updated
- 21 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. 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 Post Cataract Extraction Macular Edema
- ClinicalTrials.gov ID
- NCT00135655
- Acronym / sponsor ID
- 06-104
- Conditions
- Macular Edema, Cystoid
- Keywords
- macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 26 Aug 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 investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.
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 (5 listed)
- Have persistent post cataract extraction macular edema whose condition is stable
- Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
- Have at least one eligible eye to be treated in the study
- Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
- Have macular edema confirmed by fluorescein angiography
Key exclusion criteria (8 listed)
- Have proliferative vitreoretinopathy greater than grade B in either eye
- Have ocular disorders in the study eye that may confound interpretation of study results
- Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
- Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
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
safety
tolerability
retinal thickness
visual acuity
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 21 May 2013.
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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
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing denufosol tetrasodium (INS37217) Intravitreal Injection in people with Macular Edema, Cystoid, 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 5 inclusion and 8 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 21 May 2013. 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 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?
safety. The study lists 4 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 21 May 2013.