The Standard Care vs. COrticosteroid for REtinal Vein Occ... | NCT00105027

ID	Type	Link
5U10EY014351-05	U.S. NIH Grant/Contract	View source
5U10EY014404	U.S. NIH Grant/Contract	View source
5U10EY014352	U.S. NIH Grant/Contract	View source

Name	Class
National Eye Institute (NEI)	NIH
Allergan	INDUSTRY

The Standard Care vs. COrticosteroid for REtinal Vein Occ... | NCT00105027 | Trialant

Description Module

Detailed Description

Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and BRVO are common retinal problems and are caused by a blockage in one of the large retinal veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein occlusion - BRVO). Currently, there is no effective treatment for macular edema associated with CRVO and standard care treatment is observation. Grid laser photocoagulation may be effective for some patients for macular edema associated with BRVO, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities for macular edema caused by these two conditions is an important research goal.

Over the last several years, many patients with macular edema from CRVO and BRVO have been treated with an injection of a type of steroid called triamcinolone directly into the eye. This type of injection is called an intravitreal injection. The triamcinolone preparation commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and joints. The SCORE Study will use a formulation of triamcinolone made specifically for the eye.

The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness and safety of standard care versus triamcinolone injection(s) for the treatment of macular edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will be randomized (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After randomization, participants will be examined every 4 months through 3 years to collect ophthalmic information, including visual acuity, intraocular pressure, optical coherence tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and 24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be provided as clinically indicated based on protocol-specific guidelines.

The primary outcome is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as assessed by stereoscopic color fundus photography and optical coherence tomography, and adverse ocular outcomes.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CRVO Observation	Active Comparator	Other: Standard Care
CRVO 1 mg dose triamcinolone acetonide	Active Comparator	Drug: intravitreal triamcinolone injection
CRVO 4 mg dose triamcinolone acetonide	Active Comparator	Drug: intravitreal triamcinolone injection
BRVO standard care	Active Comparator	Other: Standard Care
BRVO 1 mg dose triamcinolone acetonide	Active Comparator	Drug: intravitreal triamcinolone injection
BRVO 4 mg dose triamcinolone acetonide	Active Comparator	Drug: intravitreal triamcinolone injection

Name	Type	Description	Arm Group Labels	Other Names
Standard Care	Other	CRVO: observation; BRVO: standard care	BRVO standard care CRVO Observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit	Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.	Change from baseline to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Changes From Baseline in Best-corrected ETDRS Visual Acuity Score		12 months
Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography		12 months

Contacts/Locations Module

Name	Affiliation	Role
Michael S. Ip, M.D.	University of Wisconsin, Madison	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53711	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17765429	Background	Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.
19167078	Background	Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Jumper JM, Figueroa M; SCORE Study Investigator Group. SCORE Study report 1: baseline associations between central retinal thickness and visual acuity in patients with retinal vein occlusion. Ophthalmology. 2009 Mar;116(3):504-12. doi: 10.1016/j.ophtha.2008.10.017. Epub 2009 Jan 22.

Arm/Group Information

ID	Title	Description
FG000	CRVO Observation	Standard care consists of observation of the macular edema.
FG001	CRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
FG002	CRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
FG003	BRVO Standard Care	Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
FG004	BRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
FG005	BRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00088 subjects FG00192 subjects FG00291 subjects FG003137 subjects FG004136 subjects FG005138 subjects
COMPLETED		FG00073 subjects FG00183 subjects FG00282 subjects FG003121 subjects FG004
NOT COMPLETED		FG00015 subjects FG0019 subjects FG0029 subjects FG00316 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CRVO Observation	Standard care consists of observation of the macular edema.
BG001	CRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

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

The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit

Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.

Posted

Number

Participants

Change from baseline to 12 months

ID	Title	Description
OG000	CRVO Observation	Standard care consists of observation of the macular edema.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CRVO Observation	Standard care consists of observation of the macular edema.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Blepharitis	Eye disorders	MedDRA 12.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Paul C. VanVeldhuisen, Ph.D.	The EMMES Corporation	301-251-1161		score@emmes.com

Uploaded Document Information

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	Feb 10, 2008	Jan 30, 2018	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Jul 9, 2007	Jan 30, 2018	ICF_001.pdf

Condition Browse Module

ID	Term
D008269	Macular Edema
D012170	Retinal Vein Occlusion

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Intervention Browse Module

ID	Term
D059039	Standard of Care

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Secondary

Changes From Baseline in Best-corrected ETDRS Visual Acuity Score

Participants who attended month 12 visit

Posted

Mean

95% Confidence Interval

letters read

12 months

ID	Title	Description
OG000	CRVO Observation	Standard care consists of observation of the macular edema.
OG001	CRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
OG002	CRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
OG003	BRVO Standard Care	Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
OG004	BRVO 1 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
OG005	BRVO 4 mg Dose Triamcinolone Acetonide	Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).

Units	Counts
Participants	OG00073 OG00183 OG00282 OG003

Title

Denominators