Trial Outcomes & Findings for Topical Interferon Gamma-1b for Central Serous Chorioretinopathy (NCT NCT01468337)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Week 48

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Interferon Gamma-1b Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Overall Study STARTED	5
Overall Study Week 2	5
Overall Study Received Interferon Gamma-1b at Week 4	2
Overall Study Received Interferon Gamma-1b After Wk 8	4
Overall Study Week 48	3
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Interferon Gamma-1b for Central Serous Chorioretinopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Total Number of Severe Ocular Adverse Events Related to the Investigational Product	0 Adverse Events

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Total Number of Ocular Adverse Events Related to Investigational Product	7 Adverse Events

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product	0 Adverse Events

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Total Number of Non-ocular Adverse Events Related to the Investigational Product	0 Adverse Events

PRIMARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Participants Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Number of Participants Who Withdrew From the Study	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 2

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Eyes Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline	0.4 ETDRS letters Interval -3.0 to 5.0

SECONDARY outcome

Timeframe: Baseline and Week 2

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=5 Eyes Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline	0.80 ETDRS letters Interval -2.0 to 7.0

SECONDARY outcome

Timeframe: Baseline and Week 48

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.

Outcome measures

Outcome measures
Measure	Interferon Gamma-1b n=3 Eyes Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product. All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg.
Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline	2.67 ETDRS letters Interval -3.0 to 13.0

SECONDARY outcome

Timeframe: Baseline and Week 48

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome.