Epiretinal MembranePhase 2NCT00333060
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
A Phase 2 study testing OT-551 ophthalmic solution in people with Epiretinal Membrane and Macular Hole, run by Othera Pharmaceuticals at 16 sites in United States.
Trial summary
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Hole
- What is being tested?
- OT-551 ophthalmic solution
- How many people
- 164 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2005to Jan 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imminent vitrectomy to repair macular holes or puckers
- Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
- Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye
Who cannot join
- Artificial lens or no lens in the surgical eye
- Cataract (greater than slight opacity or thickness) in the surgical eye
- Any other retinal abnormality which may be vision-threatening
- Serious heart, kidney, or liver disease
- Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
- Poorly controlled diabetes or unstable glaucoma
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Abilene, Texas
Study site
Bala-Cynwyd, Pennsylvania
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Cherry Hill, New Jersey
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Denver, Colorado
Study site
Forrest Hills, New Jersey
Study site
Joliet, Illinois
Study site
Miami, Florida
Study site
New York, New York
Study site
Peoria, Arizona
Study site
Sacramento, California
Study site
Tallahassee, Florida
Study site
West Chester, Pennsylvania
About this study
Official title: Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.
- Conditions
- Epiretinal Membrane, Macular Hole
- Being tested
- OT-551 ophthalmic solution
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-551 ophthalmic solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in visual acuity
change in lens opacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startNov 2005
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Othera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333060
- Sponsor's protocol ID
- OT-551-002
- Status last verified
- Mar 2008
- First submitted
- 31 May 2006
- Last updated
- 2 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
- ClinicalTrials.gov ID
- NCT00333060
- Acronym / sponsor ID
- OT-551-002
- Conditions
- Epiretinal Membrane, Macular Hole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Othera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Jan 2008 (estimated)
- First posted
- 2 Jun 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.
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Imminent vitrectomy to repair macular holes or puckers
- Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
- Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye
Key exclusion criteria (6 listed)
- Artificial lens or no lens in the surgical eye
- Cataract (greater than slight opacity or thickness) in the surgical eye
- Any other retinal abnormality which may be vision-threatening
- Serious heart, kidney, or liver disease
- Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 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 |
|---|---|---|
| OT-551 ophthalmic solution | Drug | – |
Primary outcome
change in visual acuity
change in lens opacity
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 2 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OT-551 ophthalmic solution in people with Epiretinal Membrane and Macular Hole, run by Othera Pharmaceuticals at 16 sites 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 3 inclusion and 6 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 2 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 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?
change in visual acuity. 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 2 Apr 2008.