Trial Outcomes & Findings for Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS) (NCT NCT02338973)

NCT ID: NCT02338973

Last Updated: 2019-08-13

Results Overview

The number and severity of adverse events related to the investigation product (IP).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Study duration, up to 52 weeks
• Results posted on: 2019-08-13

Participant Flow

People with rod-cone dystrophy (RCD) and enhanced S-cone syndrome (ESCS) were combined as pre-specified in the study protocol

Participant milestones

Measure	Interferon Gamma-1b Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Overall Study STARTED	4
Overall Study Rod-cone Dystrophy (RCD)	2
Overall Study Enhanced S-Cone Syndrome (ESCS)	2
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS)

Baseline characteristics by cohort

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.8 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Study duration, up to 52 weeks

The number and severity of adverse events related to the investigation product (IP).

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Number and Severity of IP-related AEs Severity: Mild	3 adverse events related to IP	—	—	—	—	—
Number and Severity of IP-related AEs Severity: Severe	1 adverse events related to IP	—	—	—	—	—

PRIMARY outcome

Timeframe: Study duration, up to 52 weeks

The number of participants who withdrew early.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Number of Participants Who Withdrew	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: BCVA values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Day 1 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1 Participant 001	77 letters read	80 letters read	76 letters read	79 letters read	-1 letters read	-1 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1 Participant 002	39 letters read	61 letters read	32 letters read	62 letters read	-7 letters read	1 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1 Participant 003	69 letters read	76 letters read	74 letters read	70 letters read	5 letters read	-6 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1 Participant 004	14 letters read	42 letters read	18 letters read	44 letters read	4 letters read	2 letters read

SECONDARY outcome

Timeframe: Day 2

Population: BCVA values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Day 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2 Participant 001	77 letters read	80 letters read	75 letters read	81 letters read	-2 letters read	1 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2 Participant 002	39 letters read	61 letters read	36 letters read	58 letters read	-3 letters read	-3 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2 Participant 003	69 letters read	76 letters read	75 letters read	69 letters read	6 letters read	-7 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2 Participant 004	14 letters read	42 letters read	21 letters read	45 letters read	7 letters read	3 letters read

SECONDARY outcome

Timeframe: Day 3

Population: BCVA values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Day 3 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3 Participant 003	69 letters read	76 letters read	74 letters read	73 letters read	5 letters read	-3 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3 Participant 001	77 letters read	80 letters read	81 letters read	78 letters read	4 letters read	-2 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3 Participant 002	39 letters read	61 letters read	41 letters read	61 letters read	2 letters read	0 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3 Participant 004	14 letters read	42 letters read	23 letters read	47 letters read	9 letters read	5 letters read

SECONDARY outcome

Timeframe: Week 2

Population: BCVA values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Week 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2 Participant 001	77 letters read	80 letters read	75 letters read	78 letters read	-2 letters read	-2 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2 Participant 002	39 letters read	61 letters read	0 letters read	66 letters read	-39 letters read	5 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2 Participant 003	69 letters read	76 letters read	66 letters read	67 letters read	-3 letters read	-9 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2 Participant 004	14 letters read	42 letters read	23 letters read	42 letters read	9 letters read	0 letters read

SECONDARY outcome

Timeframe: Week 5

Population: BCVA values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Week 5 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5 Participant 001	77 letters read	80 letters read	71 letters read	82 letters read	-6 letters read	2 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5 Participant 002	39 letters read	61 letters read	0 letters read	65 letters read	-39 letters read	4 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5 Participant 003	69 letters read	76 letters read	72 letters read	75 letters read	3 letters read	-1 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5 Participant 004	14 letters read	42 letters read	26 letters read	45 letters read	12 letters read	3 letters read

SECONDARY outcome

Timeframe: Week 8

Population: BCVA values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Week 8 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8 Participant 001	77 letters read	80 letters read	74 letters read	80 letters read	-3 letters read	0 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8 Participant 002	39 letters read	61 letters read	43 letters read	65 letters read	4 letters read	4 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8 Participant 003	69 letters read	76 letters read	72 letters read	70 letters read	3 letters read	-6 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8 Participant 004	14 letters read	42 letters read	24 letters read	47 letters read	10 letters read	5 letters read

SECONDARY outcome

Timeframe: Week 52

Population: BCVA values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).

Change in BCVA from baseline as compared to Week 52 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52 Participant 001	77 letters read	80 letters read	79 letters read	78 letters read	2 letters read	-2 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52 Participant 002	39 letters read	61 letters read	47 letters read	65 letters read	8 letters read	4 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52 Participant 003	69 letters read	76 letters read	65 letters read	65 letters read	-4 letters read	-11 letters read
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52 Participant 004	14 letters read	42 letters read	20 letters read	44 letters read	6 letters read	2 letters read

SECONDARY outcome

Timeframe: Day 1

Population: Subretinal Fluid Volume values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1 Participant 001	7.25 mm^3	7.1 mm^3	7.35 mm^3	7.35 mm^3	0.1 mm^3	0.25 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1 Participant 002	14.15 mm^3	11.2 mm^3	13.95 mm^3	11.25 mm^3	-0.2 mm^3	0.05 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1 Participant 003	16.1 mm^3	18.55 mm^3	15.15 mm^3	17.2 mm^3	-0.95 mm^3	-1.35 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1 Participant 004	36.3 mm^3	9.25 mm^3	37.7 mm^3	9.2 mm^3	1.4 mm^3	-0.05 mm^3

SECONDARY outcome

Timeframe: Day 2

Population: Subretinal Fluid Volume values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2 Participant 001	7.25 mm^3	7.1 mm^3	7.1 mm^3	7 mm^3	-0.15 mm^3	-0.1 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2 Participant 002	14.15 mm^3	11.2 mm^3	14.1 mm^3	10.9 mm^3	-0.05 mm^3	-0.3 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2 Participant 003	16.1 mm^3	18.55 mm^3	15.15 mm^3	15.55 mm^3	-0.95 mm^3	-3 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2 Participant 004	36.3 mm^3	9.25 mm^3	37.3 mm^3	9.05 mm^3	1 mm^3	-0.2 mm^3

SECONDARY outcome

Timeframe: Day 3

Population: Subretinal Fluid Volume values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3 Participant 001	7.25 mm^3	7.1 mm^3	7.5 mm^3	7.45 mm^3	0.25 mm^3	0.35 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3 Participant 002	14.15 mm^3	11.2 mm^3	13.75 mm^3	11.25 mm^3	-0.4 mm^3	0.05 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3 Participant 003	16.1 mm^3	18.55 mm^3	15.3 mm^3	17 mm^3	-0.8 mm^3	-1.55 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3 Participant 004	36.3 mm^3	9.25 mm^3	35 mm^3	9.1 mm^3	-1.3 mm^3	-0.15 mm^3

SECONDARY outcome

Timeframe: Week 2

Population: Subretinal Fluid Volume values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2 Participant 001	7.25 mm^3	7.1 mm^3	7.6 mm^3	7.3 mm^3	0.35 mm^3	0.2 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2 Participant 002	14.15 mm^3	11.2 mm^3	13.1 mm^3	11 mm^3	-1.05 mm^3	-0.2 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2 Participant 003	16.1 mm^3	18.55 mm^3	14.3 mm^3	17 mm^3	-1.8 mm^3	-1.55 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2 Participant 004	36.3 mm^3	9.25 mm^3	32.5 mm^3	9 mm^3	-3.8 mm^3	-0.25 mm^3

SECONDARY outcome

Timeframe: Week 5

Population: Subretinal Fluid Volume values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5 Participant 001	7.25 mm^3	7.1 mm^3	7.4 mm^3	7.3 mm^3	0.15 mm^3	0.2 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5 Participant 002	14.15 mm^3	11.2 mm^3	13.9 mm^3	11.2 mm^3	-0.25 mm^3	0 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5 Participant 003	16.1 mm^3	18.55 mm^3	14 mm^3	15.7 mm^3	-2.1 mm^3	-2.85 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5 Participant 004	36.3 mm^3	9.25 mm^3	29.1 mm^3	9.1 mm^3	-7.2 mm^3	-0.15 mm^3

SECONDARY outcome

Timeframe: Week 8

Population: Subretinal Fluid Volume values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8 Participant 001	7.25 mm^3	7.1 mm^3	7.4 mm^3	7.4 mm^3	0.15 mm^3	0.3 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8 Participant 002	14.15 mm^3	11.2 mm^3	13.5 mm^3	10.9 mm^3	-0.65 mm^3	-0.3 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8 Participant 003	16.1 mm^3	18.55 mm^3	13.8 mm^3	17.1 mm^3	-2.3 mm^3	-1.45 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8 Participant 004	36.3 mm^3	9.25 mm^3	27.6 mm^3	9.4 mm^3	-8.7 mm^3	0.15 mm^3

SECONDARY outcome

Timeframe: Week 52

Population: Subretinal Fluid Volume values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).

Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52 Participant 001	7.25 mm^3	7.1 mm^3	6.9 mm^3	7 mm^3	-0.35 mm^3	-0.1 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52 Participant 002	14.15 mm^3	11.2 mm^3	12.7 mm^3	11.3 mm^3	-1.45 mm^3	0.1 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52 Participant 003	16.1 mm^3	18.55 mm^3	13.8 mm^3	14.3 mm^3	-2.3 mm^3	-4.25 mm^3
Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52 Participant 004	36.3 mm^3	9.25 mm^3	32.3 mm^3	8.9 mm^3	-4 mm^3	-0.35 mm^3

SECONDARY outcome

Timeframe: Day 1

Population: Central Retinal Thickness values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1 Participant 001	297.5 μm	269 μm	314 μm	270.5 μm	16.5 μm	1.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1 Participant 002	597 μm	285 μm	602 μm	298.5 μm	5 μm	13.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1 Participant 003	713 μm	784 μm	598 μm	713.5 μm	-115 μm	-70.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1 Participant 004	1393 μm	241.5 μm	1394.5 μm	232.5 μm	1.5 μm	-9 μm

SECONDARY outcome

Timeframe: Day 2

Population: Cirrus OCT values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2 Participant 001	297.5 μm	269 μm	309.5 μm	279 μm	12 μm	10 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2 Participant 002	597 μm	285 μm	605 μm	304.5 μm	8 μm	19.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2 Participant 003	713 μm	784 μm	613 μm	700.5 μm	-100 μm	-83.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2 Participant 004	1393 μm	241.5 μm	1392.5 μm	220 μm	-0.5 μm	-21.5 μm

SECONDARY outcome

Timeframe: Day 3

Population: Cirrus OCT values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3 Participant 001	297.5 μm	269 μm	323 μm	274 μm	25.5 μm	5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3 Participant 002	597 μm	285 μm	587.5 μm	299 μm	-9.5 μm	14 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3 Participant 003	713 μm	784 μm	621 μm	682.5 μm	-92 μm	-101.5 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3 Participant 004	1393 μm	241.5 μm	1361.5 μm	220 μm	-31.5 μm	-21.5 μm

SECONDARY outcome

Timeframe: Week 2

Population: Cirrus OCT values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2 Participant 001	297.5 μm	269 μm	330 μm	267 μm	32.5 μm	-2 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2 Participant 002	597 μm	285 μm	534 μm	300 μm	-63 μm	15 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2 Participant 003	713 μm	784 μm	517 μm	700 μm	-196 μm	-84 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2 Participant 004	1393 μm	241.5 μm	1193 μm	208 μm	-200 μm	-33.5 μm

SECONDARY outcome

Timeframe: Week 5

Population: Cirrus OCT values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5 Participant 001	297.5 μm	269 μm	374 μm	276 μm	76.5 μm	7 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5 Participant 002	597 μm	285 μm	605 μm	302 μm	8 μm	17 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5 Participant 003	713 μm	784 μm	473 μm	580 μm	-240 μm	-204 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5 Participant 004	1393 μm	241.5 μm	1083 μm	206 μm	-310 μm	-35.5 μm

SECONDARY outcome

Timeframe: Week 8

Population: Cirrus OCT values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8 Participant 001	297.5 μm	269 μm	353 μm	276 μm	55.5 μm	7 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8 Participant 002	597 μm	285 μm	544 μm	224 μm	-53 μm	-61 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8 Participant 003	713 μm	784 μm	456 μm	667 μm	-257 μm	-117 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8 Participant 004	1393 μm	241.5 μm	1000 μm	220 μm	-393 μm	-21.5 μm

SECONDARY outcome

Timeframe: Week 52

Population: Cirrus OCT values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52 Participant 001	297.5 μm	269 μm	302 μm	270 μm	4.5 μm	1 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52 Participant 002	597 μm	285 μm	503 μm	307 μm	-94 μm	22 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52 Participant 003	713 μm	784 μm	437 μm	457 μm	-276 μm	-327 μm
Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52 Participant 004	1393 μm	241.5 μm	1175 μm	197 μm	-218 μm	-44.5 μm

SECONDARY outcome

Timeframe: Day 1

Population: Central Retinal Thickness values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1 Participant 001	307 μm	278 μm	331 μm	275 μm	24 μm	-3 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1 Participant 002	619 μm	319 μm	607 μm	317 μm	-12 μm	-2 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1 Participant 003	702 μm	745 μm	605 μm	703 μm	-97 μm	-42 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1 Participant 004	1413 μm	260 μm	1418 μm	258 μm	5 μm	-2 μm

SECONDARY outcome

Timeframe: Day 2

Population: Central Retinal Thickness values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2 Participant 001	307 μm	278 μm	321 μm	278 μm	14 μm	0 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2 Participant 002	619 μm	319 μm	611 μm	318 μm	-8 μm	-1 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2 Participant 003	702 μm	745 μm	624 μm	682 μm	-78 μm	-63 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2 Participant 004	1413 μm	260 μm	1427 μm	246 μm	14 μm	-14 μm

SECONDARY outcome

Timeframe: Day 3

Population: Central Retinal Thickness values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3 Participant 001	307 μm	278 μm	330 μm	277 μm	23 μm	-1 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3 Participant 002	619 μm	319 μm	587 μm	320 μm	-32 μm	1 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3 Participant 003	702 μm	745 μm	607 μm	656 μm	-95 μm	-89 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3 Participant 004	1413 μm	260 μm	1393 μm	243 μm	-20 μm	-17 μm

SECONDARY outcome

Timeframe: Week 2

Population: Central Retinal Thickness values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2 Participant 001	307 μm	278 μm	333 μm	276 μm	26 μm	-2 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2 Participant 002	619 μm	319 μm	530 μm	317 μm	-89 μm	-2 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2 Participant 003	702 μm	745 μm	552 μm	687 μm	-150 μm	-58 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2 Participant 004	1413 μm	260 μm	1233 μm	234 μm	-180 μm	-26 μm

SECONDARY outcome

Timeframe: Week 5

Population: Central Retinal Thickness values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5 Participant 001	307 μm	278 μm	385 μm	282 μm	78 μm	4 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5 Participant 002	619 μm	319 μm	576 μm	316 μm	-43 μm	-3 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5 Participant 003	702 μm	745 μm	509 μm	591 μm	-193 μm	-154 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5 Participant 004	1413 μm	260 μm	1089 μm	243 μm	-324 μm	-17 μm

SECONDARY outcome

Timeframe: Week 8

Population: Central Retinal Thickness values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8 Participant 003	702 μm	745 μm	486 μm	657 μm	-216 μm	-88 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8 Participant 004	1413 μm	260 μm	1020 μm	250 μm	-393 μm	-10 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8 Participant 001	307 μm	278 μm	370 μm	280 μm	63 μm	2 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8 Participant 002	619 μm	319 μm	545 μm	313 μm	-74 μm	-6 μm

SECONDARY outcome

Timeframe: Week 52

Population: Central Retinal Thickness values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).

Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye n=3 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye n=3 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52 Participant 001	307 μm	278 μm	309 μm	277 μm	2 μm	-1 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52 Participant 002	619 μm	319 μm	497 μm	—	-122 μm	—
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52 Participant 003	702 μm	745 μm	445 μm	472 μm	-257 μm	-273 μm
Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52 Participant 004	1413 μm	260 μm	1221 μm	233 μm	-192 μm	-27 μm

SECONDARY outcome

Timeframe: Day 2 and Week 5

Change in central visual field sensitivity as measured by microperimetry testing at Day 2 and Week 5 compared to baseline in both study and fellow eyes.

Outcome measures

Measure	Interferon Gamma-1b n=4 Participants Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	BCVA at Day 1 in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Study Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b	Difference in BCVA at Day 1 From Baseline in Fellow Eye Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline. Day 2 Study Eye	-0.3 dB Standard Deviation 1.6	—	—	—	—	—
Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline. Day 2 Fellow Eye	-1.4 dB Standard Deviation 0.6	—	—	—	—	—
Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline. Week 5 Study Eye	-1.1 dB Standard Deviation 1.1	—	—	—	—	—
Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline. Week 5 Fellow Eye	-1.7 dB Standard Deviation 1.4	—	—	—	—	—

Adverse Events

Interferon Gamma-1b

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Interferon Gamma-1b n=4 participants at risk Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Eye disorders Visual Acuity Reduced	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.

Other adverse events

Measure	Interferon Gamma-1b n=4 participants at risk Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
Eye disorders Ocular Hyperaemia	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Eye disorders Lacrimation Increased	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Eye disorders Eye Pruritus	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Eye disorders Cystoid Macular Oedema	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Musculoskeletal and connective tissue disorders Back Pain	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Eye disorders Retinal Telangiectasia	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.
Eye disorders Diabetic Retinopathy	25.0% 1/4 • Number of events 1 • Up to 52 Weeks Adverse events were collected on and after the baseline visit, and when investigational product (IP) began.

Additional Information

Wadih Zein, MD, Principal Investigator, NEI

National Institutes of Health

Phone: 301-496-8118

Email: zeinw@nei.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place