Trial Outcomes & Findings for 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 (NCT NCT02251938)

NCT ID: NCT02251938

Last Updated: 2020-02-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2020-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	DE-109 440 μg Medium dose of DE-109
Overall Study STARTED	60
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DE-109 440 μg n=60 Participants Medium dose of DE-109
Age, Continuous	43.31 years STANDARD_DEVIATION 15.092 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	47 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	3 Participants n=5 Participants
Geographic Region United States	33 Participants n=5 Participants
Geographic Region India	17 Participants n=5 Participants
Geographic Region Europe, the Middle East and Africa	10 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye	2.1 ETDRS Letters Standard Deviation 11.35

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye	0.3 mmHg Standard Deviation 4.16

PRIMARY outcome

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

Ophthalmoscopy findings were reported as normal or abnormal.

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. Normal to Normal	36 Subjects
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. Normal to Abnormal	0 Subjects
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. Abnormal to Normal	4 Subjects
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. Abnormal to Abnormal	3 Subjects

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12	-0.09 score on a scale Standard Deviation 0.847

PRIMARY outcome

Timeframe: By Month12

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.

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=60 Participants Medium dose of DE-109
Number of Subjects Who Receive Rescue Therapy.	9 Participants

PRIMARY outcome

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

Ophthalmoscopy findings were reported as normal or abnormal.

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. Normal to Normal	20 Subjects
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. Normal to Abnormal	2 Subjects
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. Abnormal to Normal	6 Subjects
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. Abnormal to Abnormal	15 Subjects

PRIMARY outcome

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

Ophthalmoscopy findings were reported as normal or abnormal.

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. Normal to Normal	39 Subjects
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. Normal to Abnormal	2 Subjects
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. Abnormal to Normal	0 Subjects
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. Abnormal to Abnormal	2 Subjects

PRIMARY outcome

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

Ophthalmoscopy findings were reported as normal or abnormal.

Outcome measures

Outcome measures
Measure	DE-109 440 μg n=43 Participants Medium dose of DE-109
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. Normal to Normal	34 Subjects
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. Normal to Abnormal	2 Subjects
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. Abnormal to Normal	1 Subjects
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. Abnormal to Abnormal	6 Subjects

Adverse Events

DE-109 440 μg

Serious events: 8 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DE-109 440 μg n=60 participants at risk Medium dose of DE-109 DE-109: Medium Dose of DE-109
Eye disorders Cataract	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Visual Acuity Reduced	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Vitreous Hemorrhage	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Investigations Intraocular Pressure Increased	3.3% 2/60 • Number of events 2 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Nervous system disorders Cerebrovascular Accident	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Nervous system disorders Trigeminal Neuralgia	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Infections and infestations Cellulitis Gangrenous	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Injury, poisoning and procedural complications Procedural Complication	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Musculoskeletal and connective tissue disorders Pathological Fracture	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Metastatic	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Vascular disorders Arterial Occlusive Disease	1.7% 1/60 • Number of events 1 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.

Other adverse events

Other adverse events
Measure	DE-109 440 μg n=60 participants at risk Medium dose of DE-109 DE-109: Medium Dose of DE-109
Eye disorders Uveitis	13.3% 8/60 • Number of events 16 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Cystoid Macular Oedema	10.0% 6/60 • Number of events 9 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Intermediate Uvei	10.0% 6/60 • Number of events 12 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Iridocyclitis	5.0% 3/60 • Number of events 3 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Eye disorders Macular Fibrosis	5.0% 3/60 • Number of events 4 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Investigations Intraocular Pressure Increased	11.7% 7/60 • Number of events 9 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Investigations Intraocular Pressure Decreased	5.0% 3/60 • Number of events 5 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.
Infections and infestations Sinusitis	5.0% 3/60 • Number of events 3 • An on-study Adverse Events (AEs) were collected after the date of the written informed consent until the Last Study Visit at Month 12 or early termination visit.

Additional Information

R&D Quality Manager

Santen Inc

Phone: +1 415 268 9199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place