A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program

NCT02251938 | Completed Phase 3 Results

• 1 other identifier: 32-009
• Study Type: interventional
• Target: 60
• Locations: 6 countries
• Sites: 25

Brief Summary

The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.

Conditions

Non-Infectious Uveitis of the Posterior Segment of the Eye

Outcome Measures

Primary Outcomes (8)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye

  Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.

  Day 1 (Baseline) and Month 12 or early termination visit

• Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye

  Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.

  Day 1 (Baseline) and Month 12 or early termination visit

• Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.

  Ophthalmoscopy findings were reported as normal or abnormal.

  Day 1 (Baseline) and Month 12 or early termination visit

• Changes From Baseline in Vitreous Haze (VH) Scores at Month 12

  Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) : 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

  Day 1 (Baseline) and Month 12 or early termination visit

• Number of Subjects Who Receive Rescue Therapy.

  Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.

  By Month12

• Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.

  Ophthalmoscopy findings were reported as normal or abnormal.

  Day 1 (Baseline) and Month 12 or early termination visit

• Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.

  Ophthalmoscopy findings were reported as normal or abnormal.

  Day 1 (Baseline) and Month 12 or early termination visit

• Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.

  Ophthalmoscopy findings were reported as normal or abnormal.

  Day 1 (Baseline) and Month 12 or early termination visit

Study Arms (1)

DE-109 Sirolimus

EXPERIMENTAL

DE-109 440 μg

Drug: DE-109 440 μg

Interventions

DE-109 440 μg DRUG

Medium Dose

Also known as: Sirolimus

DE-109 Sirolimus

Eligibility Criteria

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

You may qualify if:

• Participated in the SAKURA study
• Received clinical benefit from treatment in the SAKURA study
• Ability to sign informed consent and attend all study visits

You may not qualify if:

• Uveitis of infectious etiology
• Implanted device
• Suspected or confirmed central nervous system or ocular lymphoma
• Uncontrolled glaucoma
• Significant ocular disease
• Intravitreal injections in the past 60 days
• Intraocular surgery or treatment
• Ocular or periocular infection
• History of herpetic infection
• Toxoplasmosis or toxoplasmosis scar
• Ocular malignancy
• Vitrectomy
• Allergy or hypersensitivity to study drug
• Participation in other uveitis device clinical trials within 30 days
• Any recent systemic condition/infection

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (25)

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Phoenix, Arizona, United States

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Sacramento, California, United States

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Golden, Colorado, United States

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Tampa, Florida, United States

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Oak Park, Illinois, 60304, United States

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Jackson, Michigan, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

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Palisades Park, New Jersey, 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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Austin, Texas, United States

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Salt Lake City, Utah, United States

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Graz, Austria

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Paris, France

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Hyderabad, Andhra Pradesh, India

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Aurobindo Marg, New Dehli, India

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Daryāganj, New Dehli, India

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Bhubaneswar, Odisha, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Noida, Uttar Pradesh, India

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Milan, Italy

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Ankara, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: R&D Quality Manager
• Organization: Santen Inc

evelyn.chikere@santen.com

+1 415 268 9199

Study Officials

• Lanita Scott, MD

  Santen Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 29, 2014
• Study Start: September 29, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 27, 2017
• Last Updated: February 12, 2020
• Results First Posted: February 12, 2020

Record last verified: 2020-01

Locations

US (13); AU (1); FR (1); IN (7); TU (2); IT (1)