Clinical Trials

A Study Assessing the Effectiveness and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Rochester, MN

See details

A Study Assessing the Effectiveness and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
III
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the effectiveness and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-000598
NCT ID:
NCT03711929
Sponsor Protocol Number:
010906IN

A Study to Assess the Effectiveness and Safety of Intravitreal 440 ug DE-109 Sirolimus Injections for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Jacksonville, FL

See details

A Study to Assess the Effectiveness and Safety of Intravitreal 440 ug DE-109 Sirolimus Injections for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
III
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the effectiveness and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 18-011758
NCT ID:
NCT03711929
Sponsor Protocol Number:
010906IN

Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus

Rochester, MN

See details

Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This study is being done to:

- Assess what children with different eye conditions experience in everyday life

- Improve our understanding of the difficulties that children with eye problems experience

- Improve reporting of how parents see their child’s eye condition affecting them

- Assess what parents of children with different eye conditions experience in their own everyday life

- Improve the way we assess the benefits of treatment

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 14-003441
Sponsor Protocol Number:
14-003441

A Study to Compare ADalimumab vs. Conventional ImmunoSupprEssion for Uveitis

Rochester, MN

See details

A Study to Compare ADalimumab vs. Conventional ImmunoSupprEssion for Uveitis

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
III
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary purpose of this study is to compare the relative effectiveness of adalimumab vs. conventional immunosuppression at controlling ocular inflammation while permitting tapering of prednisone to < 7.5 mg/day.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-002619
NCT ID:
NCT03828019
Sponsor Protocol Number:
9196

Filter Results

Locations

Study status

Gender

Age

Study phase

Search Results 1-4 of 4 for Uveitis

A Study Assessing the Effectiveness and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

A Study to Assess the Effectiveness and Safety of Intravitreal 440 ug DE-109 Sirolimus Injections for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus

A Study to Compare ADalimumab vs. Conventional ImmunoSupprEssion for Uveitis

Mayo Clinic Footer

Legal Conditions and Terms

Advertising

Reprint Permissions