Interferon Gamma-1b Administered Topically for Macular Ed... | NCT02338973

ID	Type	Description	Link
15-EI-0052

Status Module

Description Module

Detailed Description

Objective:

Rod-cone dystrophy (RCD) is a term applied to a number of genetically heterogenous diseases presenting with night vision abnormalities, visual field defects and reduced rod electroretinography responses. Enhanced S-Cone syndrome (ESCS) is a rare autosomal recessive retinal disease with a developmental and a degenerative aspect. Macular cystic changes, often florid and usually resulting in a reduction of central acuity, are frequently associated with both diseases. The reason for this association is not well understood. Acetazolamide (Diamox) and Dorzolamide (Trusopt) have been reported to have variable success in reducing these cystic changes but the effect is frequently inadequate. The objective of this study is to evaluate the safety and potential efficacy of Interferon (IFN) gamma-1b administered topically for macular edema/retinal schisis cysts in RCD and ESCS. Possible disease-related pathophysiologic mechanisms will be explored using induced pluripotent stem cell (iPSC) protocols leading to iPSC-derived retinal pigment epithelium (RPE) and photoreceptor generation.

Study Population:

Up to five participants with RCD with significant macular cystic changes and up to five participants with ESCS with significant macular cystic changes will be enrolled to receive IFN gamma-1b administered topically in one eye. However, up to an additional two participants may be enrolled in order to obtain the five participants in each disease group to be included in the primary analysis if any participants withdraw from the study prior to receiving five days of treatment.

Design:

This is a single-center, prospective, uncontrolled, unmasked pilot Phase I/II study of the safety, tolerability and possible efficacy of IFN gamma-1b in participants with RCD and ESCS and macular cystic changes. One eye of up to five participants with RCD with significant macular cystic changes and up to five participants with ESCS with significant macular cystic changes [evidenced by optical coherence tomography (OCT) >275 microns central macular thickness and/or disruption of foveal contour] will receive topical IFN gamma-1b instilled as drops on the cornea. The initial stage of the study will include two participants from each disease category. Once all four participants have completed the 8-week visit, enrollment will be halted. Safety Adverse Event Review Committee members unaffiliated with the study will review the data as a preliminary assessment of safety and efficacy and to determine whether enrollment should continue. If the committee determines enrollment will continue, three additional participants with RCD and three participants with ESCS will be enrolled. The study will be completed once the final participant has received one year of follow-up.

Outcome Measures:

The primary outcome measure related to the safety and tolerability of IFN gamma-1b administered topically at the prescribed dosage for macular cystic changes in participants with RCD and ESCS will be assessed by the number and severity of adverse events related to the IP and the number of withdrawals at 52 weeks (one year) post-administration. Additional safety of IFN gamma-1b administered topically in participants with RCD and ESCS will be determined from the assessment of retinal function, ocular structure and occurrence of adverse events at all time points. Secondary outcomes include changes in visual function including visual acuity and microperimetry, and retinal imaging with OCT and fluorescein angiography.

Label	Type	Description	Intervention Names
Interferon Gamma-1b	Experimental	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks	Drug: Interferon gamma-1b

Name	Type	Description	Arm Group Labels	Other Names
Interferon gamma-1b	Drug		Interferon Gamma-1b

Measure	Description	Time Frame
Number and Severity of IP-related AEs	The number and severity of adverse events related to the investigation product (IP).	Study duration, up to 52 weeks
Number of Participants Who Withdrew	The number of participants who withdrew early.	Study duration, up to 52 weeks

Measure	Description	Time Frame
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1	Change in BCVA from baseline as compared to Day 1 by participant in both study and fellow eyes.	Day 1
Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

Participant must be 12 years of age or older.
Participant (or legal guardian or legal representative) must understand and sign the protocol informed consent.
Participant is willing to comply with the study procedures and is expected to be able to return for all study visits.
Participant must carry a clinical diagnosis of RCD or ESCS.
ESCS participant must have molecular confirmation with two alleles for NR2E3 gene mutations
Female participant of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo pregnancy tests at scheduled study visits.
Female participant of childbearing potential, and any male participant able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two reliable methods of contraception while taking the IP and six weeks after completion. Acceptable methods of contraception include:
- Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring);
- Intrauterine device;
- Barrier methods (diaphragm, condom) with spermicide; or
- Surgical sterilization (tubal ligation).

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

Participant has a history of other ocular disease likely to contribute significantly to visual disruption (e.g., optic neuropathy, glaucoma, uveitis, or other retinal disease).
Participant has had diagnosis or treatment of a malignancy (excluding non-melanoma skin cancer) within the previous five years.
Participant has received investigational treatment in another clinical study related to an ocular condition in the last six months.
Participant is pregnant, lactating, planning to become pregnant (or father a child) during the study follow-up period.
Participant is allergic to fluorescein dye.
Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study (e.g., multiple sclerosis (MS), as IFN gamma may cause MS exacerbations).

Study Eye Eligibility Criteria

A participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.

Study Eye Inclusion Criteria

The study eye must retain adequate fixation to allow for completion of protocol assessments.
The study eye must have macular cystic changes (>275 microns and/or disruption of foveal contour on OCT).

Study Eye Exclusion Criteria

The study eye has lens, cornea, or other media opacities that preclude adequate visualization and testing of the retina.
The study eye has undergone intraocular surgery within 6 months prior to enrollment.
The study eye has a disease that may confound the outcome of the study [e.g., choroidal neovascularization (CNV) in the fovea or parafoveal area].
Participant is unwilling to discontinue wearing a contact lens in the study eye during IP administration.

Study Eye Selection Criteria in Cases of Bilateral Disease

RCD and ESCS usually affect both eyes to a similar degree. In case both eyes of a participant meet the study eye eligibility criteria, the following criteria will be used to select the study eye:

The eye with more intraretinal fluid will be selected as the study eye;
If both eyes have similar levels of intraretinal fluid, the eye with worse visual acuity will be selected as the study eye;
If both eyes have the similar levels of intraretinal fluid and visual acuities, the right eye will be selected as the study eye.

Name	Affiliation	Role
Wadih Zein, M.D.	National Eye Institute (NEI)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

Results Section

Participant Flow Module

ID	Title	Description
FG000	Interferon Gamma-1b	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 27, 2016

ID	Title	Description
BG000	Interferon Gamma-1b	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Units	Counts
Participants	BG0004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number and Severity of IP-related AEs

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

Posted

Number

adverse events related to IP

Study duration, up to 52 weeks

ID	Title	Description
OG000	Interferon Gamma-1b	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Units	Counts
Participants	OG0004

Title

Denominators

Categories

Severity: Mild

Title	Measurements
	OG0003

Severity: Severe

Title	Measurements
	OG0001

Primary

Number of Participants Who Withdrew

The number of participants who withdrew early.

Posted

Count of Participants

Participants

Study duration, up to 52 weeks

ID	Title	Description
OG000	Interferon Gamma-1b	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Units	Counts
Participants	OG0004

Title	Denominators

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1

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

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

Posted

Number

letters read

Day 1

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	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
OG003	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

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2

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

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

Posted

Number

letters read

Day 2

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Day 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Day 2 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3

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

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

Posted

Number

letters read

Day 3

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Day 3 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Day 3 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2

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

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

Posted

Number

letters read

Week 2

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Week 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Week 2 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5

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

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

Posted

Number

letters read

Week 5

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Week 5 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Week 5 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8

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

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

Posted

Number

letters read

Week 8

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Week 8 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Week 8 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52

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

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

Posted

Number

letters read

Week 52

ID	Title	Description
OG000	BCVA at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	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
OG002	BCVA at Week 52 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	BCVA at Week 52 in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1

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.

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).

Posted

Number

mm^3

Day 1

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume 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
OG003	Subretinal Fluid Volume at Day1 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2

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.

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).

Posted

Number

mm^3

Day 2

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Day 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Day 2 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3

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.

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).

Posted

Number

mm^3

Day 3

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Day 3 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Day 3 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2

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.

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).

Posted

Number

mm^3

Week 2

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Week 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Week 2 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5

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.

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).

Posted

Number

mm^3

Week 5

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Week 5 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Week 5 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8

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.

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).

Posted

Number

mm^3

Week 8

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Week 8 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Week 8 in Fellow Eye

Secondary

Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52

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.

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).

Posted

Number

mm^3

Week 52

ID	Title	Description
OG000	Subretinal Fluid Volume at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Subretinal Fluid Volume at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Subretinal Fluid Volume at Week 52 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Subretinal Fluid Volume at Week 52 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1

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.

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).

Posted

Number

μm

Day 1

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness 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
OG003	Central Retinal Thickness at Day 1 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2

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.

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).

Posted

Number

μm

Day 2

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Day 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Day 2 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3

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.

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).

Posted

Number

μm

Day 3

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Day 3 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Day 3 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2

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.

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).

Posted

Number

μm

Week 2

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 2 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5

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.

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).

Posted

Number

μm

Week 5

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 5 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 5 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8

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.

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).

Posted

Number

μm

Week 8

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 8 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 8 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52

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.

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).

Posted

Number

μm

Week 52

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 52 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 52 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1

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.

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).

Posted

Number

μm

Day 1

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness 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
OG003	Central Retinal Thickness at Day 1 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2

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.

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).

Posted

Number

μm

Day 2

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Day 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Day 2 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3

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.

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).

Posted

Number

μm

Day 3

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Day 3 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Day 3 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2

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.

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).

Posted

Number

μm

Week 2

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 2 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 2 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5

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.

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).

Posted

Number

μm

Week 5

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 5 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 5 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8

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.

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).

Posted

Number

μm

Week 8

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 8 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 8 in Fellow Eye

Secondary

Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52

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.

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).

Posted

Number

μm

Week 52

ID	Title	Description
OG000	Central Retinal Thickness at Baseline in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG001	Central Retinal Thickness at Baseline in Fellow Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG002	Central Retinal Thickness at Week 52 in Study Eye	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b
OG003	Central Retinal Thickness at Week 52 in Fellow Eye

Secondary

Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline.

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.

Posted

Mean

Standard Deviation

Day 2 and Week 5

ID	Title	Description
OG000	Interferon Gamma-1b	Topical interferon (IFN) gamma-1b, 112 µg dose, administered in study eye daily for two weeks Interferon gamma-1b

Units	Counts
Participants	OG0004

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Ocular Hyperaemia	Eye disorders	MedDRA (21.0)	Systematic Assessment	Mild Redness.	EG0001 events1 affected4 at risk
Lacrimation Increased	Eye disorders	MedDRA (21.0)	Systematic Assessment	Tearing	EG0001 events1 affected4 at risk
Eye Pruritus	Eye disorders	MedDRA (18.1)	Systematic Assessment	Itching	EG0001 events1 affected4 at risk
Cystoid Macular Oedema	Eye disorders	MedDRA (21.0)	Systematic Assessment	Mild Blurring of Vision Due to Worse CME OD	EG0001 events1 affected4 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	Abdominal Pain	EG0001 events1 affected4 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	Back Pain	EG0001 events1 affected4 at risk
Retinal Telangiectasia	Eye disorders	MedDRA (21.0)	Systematic Assessment	Idiopathic Juxtafoveal heme	EG0001 events1 affected4 at risk
Diabetic Retinopathy	Eye disorders	MedDRA (21.0)	Systematic Assessment	Dot and Blot Heme OS	EG0001 events1 affected4 at risk

ID	Term
D008269	Macular Edema
D000071700	Cone-Rod Dystrophies
C564835	Enhanced S-Cone Syndrome

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D058499	Retinal Dystrophies
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities