Study Assessing Double-masked Uveitis Treatment

NCT01358266 | Completed Phase 3 Results DMC

• 1 other identifier: 32-007
• Study Type: interventional
• Target: 592
• Locations: 17 countries
• Sites: 151

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Conditions

Uveitis; Posterior, Disorder

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5

  At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation

  Day1 (Baseline) and Month 5 (Day150)

Secondary Outcomes (2)

• VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)

  Day1/Baseline and Day150/Month 5

• VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)

  Day1/Baseline and Day150/Month 5

Other Outcomes (3)

• VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)

  Day1/Baseline and Day180/Month 6

• VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)

  Day1/Baseline and Day180/Month 6

• VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)

  Day1/Baseline and Day180/Month 6

Study Arms (3)

Ophthalmic solution low dose

ACTIVE COMPARATOR

Drug: DE-109 44 ug

Ophthalmic solution medium dose

ACTIVE COMPARATOR

Drug: DE-109 440 ug

Ophthalmic solution high dose

ACTIVE COMPARATOR

Drug: DE-109 880 ug

Interventions

DE-109 44 ug DRUG

Low dose

Also known as: Sirolimus

Ophthalmic solution low dose

DE-109 440 ug DRUG

Medium dose

Also known as: Sirolimus

Ophthalmic solution medium dose

DE-109 880 ug DRUG

High dose

Also known as: Sirolimus

Ophthalmic solution high dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of active uveitis
• years of age or older
• Sign informed consent
• Meet best corrected ETDRS visual acuity

You may not qualify if:

• Uveitis of infectious etiology
• Suspected/confirmed central nervous system or ocular lymphoma
• Primary diagnosis of anterior uveitis
• Uncontrolled glaucoma
• Use of topical oculary medication
• Implanted device
• Significant ocular disease
• Lens/media opacities or obscured ocular media
• Intraocular surgery or treatments
• Capsulotomy
• Ocular or periocular infection
• Pupillary dilation
• History of herpetic infection
• Toxoplasmosis or toxoplasmosis scar
• Ocular malignancy

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (151)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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Altamonte Springs, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Oak Park, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Peabody, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Grand Rapids, Michigan, United States

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Jackson, Michigan, United States

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Royal Oak, Michigan, United States

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Southfield, Michigan, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Portsmouth, New Hampshire, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Northfield, New Jersey, United States

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Teaneck, New Jersey, United States

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Toms River, New Jersey, United States

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Albany, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Rochester, New York, United States

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Slingerlands, New York, United States

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Southern Pines, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Eugene, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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West Mifflin, Pennsylvania, United States

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Columbia, South Carolina, United States

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Ladson, South Carolina, United States

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Rapid City, South Dakota, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

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Mendoza, Argentina

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Olivos, Argentina

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Pilar, Argentina

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Rosario, Argentina

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San Juan Bautista, Argentina

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Graz, Austria

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Klagenfurt, Austria

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Americana, Brazil

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Araraquara, Brazil

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Londrina, Brazil

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Recife, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Santiago, Chile

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Bogotá, Colombia

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Cali, Colombia

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Floridablanca, Colombia

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Medellín, Colombia

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Marseille, France

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Nantes, France

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Paris, France

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Berlin, Germany

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Cologne, Germany

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Freiburg im Breisgau, Germany

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Heidelberg, Germany

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München, Germany

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Münster, Germany

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Tübingen, Germany

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Ahmedabad, India

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Bangalore, India

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Bhubaneshwar, India

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Chennai, India

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Hyderabad, India

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Kolkata, India

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Madurai, India

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Mumbai, India

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New Delhi, India

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Noida, India

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Afula, Israel

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Beersheba, Israel

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Bologna, Italy

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Florence, Italy

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Milan, Italy

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Padua, Italy

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Pisa, Italy

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Reggio Emilia, Italy

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Hokkaido, Japan

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Osaka, Japan

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Sapporo, Japan

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Sendai, Japan

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Tokyo, Japan

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Lima, Peru

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Trujillo, Peru

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Wroclaw, Poland

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Alicante, Spain

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Barcelona, Spain

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Madrid, Spain

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Santiago de Compostela, Spain

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Torrevieja, Spain

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Belfast, United Kingdom

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Bradford, United Kingdom

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Bristol, United Kingdom

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London, United Kingdom

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MeSH Terms

Conditions

Uveitis

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Clinical Operations
• Organization: Santen Inc.

clinicaltrials@santen.com

+1-415-268-9100

Study Officials

• Abu Abraham, MD

  Santen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Locations

IT (6); AU (2); BR (7); FR (3); PE (2); JP (5); IN (10); CL (1); CO (4); GB (4); AR (6); US (74); IL (8); ES (5); PL (4); TU (3); DE (7)