Ocular InflammationPhase 2NCT00353964
Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
A Phase 2 study testing rEV131 and Prenisolone sodium phosphate 1.0% in people with Ocular Inflammation, run by Evolutec Group at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Inflammation
- What is being tested?
- rEV131 and Prenisolone sodium phosphate 1.0%
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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
- be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens
Who cannot join
- have unstable glaucoma
- have an active bacterial and/or viral infection
- use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of the study.
Trial locations and contacts
1 site in 1 country.
Susan French, ORA Clinical Research & Development Inc. contact
United States1 site, 1 recruiting
- Recruiting
ORA Study Sites
North Andover, Massachusetts, 01845
ORA Site Support Center, 866-393-3767
About this study
Official title: A Multi-Center, Randomized, Double Masked, Placebo and Active Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 2.5 Mg/mL, rEV131 1.25 Mg/mL, rEV131 0.625 Mg/mL, for the Treatment of Ocular Inflammation After Cataract Surgery
The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.
- Conditions
- Ocular Inflammation
- Being tested
- rEV131, Prenisolone sodium phosphate 1.0%, rEV131 vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rEV131Drug
Prenisolone sodium phosphate 1.0%Drug
rEV131 vehicleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies 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
Sponsor and investigators
- Lead sponsor
- Evolutec Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wynne Weston-Davies, MD, Study director, Evolutec Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353964
- Sponsor's protocol ID
- EVOL-PRO-06-024
- Status last verified
- Jul 2006
- First submitted
- 17 Jul 2006
- Last updated
- 28 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Masked, Placebo and Active Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 2.5 Mg/mL, rEV131 1.25 Mg/mL, rEV131 0.625 Mg/mL, for the Treatment of Ocular Inflammation After Cataract Surgery
- ClinicalTrials.gov ID
- NCT00353964
- Acronym / sponsor ID
- EVOL-PRO-06-024
- Conditions
- Ocular Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Evolutec GroupIndustry (pharma, biotech, devices)
- First posted
- 19 Jul 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 study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.
Study design
- 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 (1 listed)
- be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens
Key exclusion criteria (3 listed)
- have unstable glaucoma
- have an active bacterial and/or viral infection
- use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of 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 |
|---|---|---|
| rEV131 | Drug | – |
| Prenisolone sodium phosphate 1.0% | Drug | – |
| rEV131 vehicle | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2006.
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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.
Susan French, ORA Clinical Research & Development Inc. contact
Wynne Weston-Davies, MD study director
Evolutec Group
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 rEV131 and Prenisolone sodium phosphate 1.0% in people with Ocular Inflammation, run by Evolutec Group 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 1 inclusion and 3 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 28 Jul 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan French, ORA Clinical Research & Development Inc. (978-685-8900 ext. 242, sfrench@oraclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Jul 2006.