Age-Related Macular DegenerationPhase 2OMEGANCT00485394
The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
A Phase 2 study testing OT-551 in people with Age-Related Macular Degeneration, run by Othera Pharmaceuticals at 17 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 treat geographic atrophy associated with age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- OT-551
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2007to Feb 2010
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a clinical diagnosis of GA in one or both eyes;
- be of non-childbearing potential
Who cannot join
- have GA secondary to any condition other than AMD in the study eye;
- have a BCVA of 20/200 or worse in the non-study eye;
- have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy;
- have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study;
- need to wear contact lenses in the study eye during the study;
- had confounding ocular surgery in the study eye;
- have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Beverly Hills, California
Study site
Boynton Beach, Florida
Study site
Charlotte, North Carolina
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Lakewood, Ohio
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
New York, New York
Study site
Novi, Michigan
Study site
Oxnard, California
Study site
Portland, Oregon
Study site
Sacramento, California
Study site
Tucson, Arizona
About this study
Official title: A Randomized, Double-Masked, Dose-Ranging, Multi-Center, Phase II Study Comparing the Safety and Efficacy of OT-551 With Placebo to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
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 treat geographic atrophy associated with age-related macular degeneration.
Read the detailed description
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- OT-551, vehicle placebo
- Keywords
- AMD, age-related macular degeneration, geographic atrophy, GA
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-551Drug
OT-551 0.3% ophthalmic solution, 2 drops 4 times daily
OT-551Drug
OT-551 0.45% ophthalmic solution, 2 drops 4 times daily
vehicle placeboDrug
OT-551 0% ophthalmic solution, 2 drops 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OT-551 0.3% ophthalmic solution Receives: Drug: OT-551 |
| 2 | Experimental | OT-551 0.45% ophthalmic solution Receives: Drug: OT-551 |
| 3 | Placebo comparator | vehicle placebo Receives: Drug: vehicle placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the area of GA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Othera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485394
- Sponsor's protocol ID
- OT-551-C04
- Acronym
- OMEGA
- Status last verified
- Mar 2008
- First submitted
- 11 Jun 2007
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Randomized, Double-Masked, Dose-Ranging, Multi-Center, Phase II Study Comparing the Safety and Efficacy of OT-551 With Placebo to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00485394
- Acronym / sponsor ID
- OMEGA / OT-551-C04
- Conditions
- Age-Related Macular Degeneration
- Keywords
- AMD, age-related macular degeneration, geographic atrophy, GA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Othera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2010 (estimated)
- First posted
- 13 Jun 2007 (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 treat geographic atrophy associated with age-related macular degeneration.
Detailed description
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OT-551OT-551 0.3% ophthalmic solution |
| 2 | Experimental | Drug: OT-551OT-551 0.45% ophthalmic solution |
| 3 | Placebo comparator | Drug: vehicle placebovehicle placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have a clinical diagnosis of GA in one or both eyes;
- be of non-childbearing potential
Key exclusion criteria (7 listed)
- have GA secondary to any condition other than AMD in the study eye;
- have a BCVA of 20/200 or worse in the non-study eye;
- have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy;
- have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study;
- need to wear contact lenses in the study eye during the study;
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-551OT-551 0.3% ophthalmic solution, 2 drops 4 times daily | Drug | 1 |
| OT-551OT-551 0.45% ophthalmic solution, 2 drops 4 times daily | Drug | 2 |
| vehicle placeboOT-551 0% ophthalmic solution, 2 drops 4 times daily | Drug | 3 |
Primary outcome
Change in the area of GA
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2008.
- Othera Pharmaceuticals, Inc. websiteLink provided by the sponsor.
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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.
17 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 in people with Age-Related Macular Degeneration, run by Othera Pharmaceuticals at 17 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 2 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 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 17 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. Some participants in this study may receive a placebo. 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?
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 the area of GA (time frame: 2 years). 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.