The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study

This study has been completed.
Sponsor:
Collaborators:
Allergan
Information provided by (Responsible Party):
The EMMES Corporation
ClinicalTrials.gov Identifier:
NCT00105027
First received: March 3, 2005
Last updated: July 9, 2012
Last verified: July 2012
Results First Received: November 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Macular Edema, Cystoid
Retinal Vein Occlusion
Interventions: Other: Standard Care
Drug: intravitreal triamcinolone injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Between November 8, 2004, and February 29, 2008, 271 patients with CRVO were enrolled from 66 clinical sites and 411 patients with BRVO were enrolled from 75 clinical sites across the United States.

Participant flow data are reported for the primary outcome measure (12 months).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CRVO Observation Standard care consists of observation of the macular edema.
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).
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).
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.
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).
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).

Participant Flow:   Overall Study
    CRVO Observation     CRVO 1 mg Dose Triamcinolone Acetonide     CRVO 4 mg Dose Triamcinolone Acetonide     BRVO Standard Care     BRVO 1 mg Dose Triamcinolone Acetonide     BRVO 4 mg Dose Triamcinolone Acetonide  
STARTED     88     92     91     137     136     138  
COMPLETED     73     83     82     121     121     125  
NOT COMPLETED     15     9     9     16     15     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CRVO Observation Standard care consists of observation of the macular edema.
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).
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).
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.
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).
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).
Total Total of all reporting groups

Baseline Measures
    CRVO Observation     CRVO 1 mg Dose Triamcinolone Acetonide     CRVO 4 mg Dose Triamcinolone Acetonide     BRVO Standard Care     BRVO 1 mg Dose Triamcinolone Acetonide     BRVO 4 mg Dose Triamcinolone Acetonide     Total  
Number of Participants  
[units: participants]
  88     92     91     137     136     138     682  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     25     35     34     62     54     55     265  
>=65 years     63     57     57     75     82     83     417  
Age  
[units: years]
Mean ± Standard Deviation
  69.2  ± 12.8     67.4  ± 12.4     67.5  ± 12.0     66.9  ± 11.5     67.2  ± 11.5     68.1  ± 10.6     67.7  ± 11.2  
Gender  
[units: participants]
             
Female     40     43     40     71     68     63     325  
Male     48     49     51     66     68     75     357  
Region of Enrollment  
[units: participants]
             
United States     88     92     91     137     136     138     682  



  Outcome Measures

1.  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   [ Time Frame: Change from baseline to 12 months ]

2.  Secondary:   Changes From Baseline in Best-corrected ETDRS Visual Acuity Score   [ Time Frame: 36 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography   [ Time Frame: 36 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Adverse Ocular Outcomes   [ Time Frame: 36 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul C. VanVeldhuisen, Ph.D.
Organization: The EMMES Corporation
phone: 301-251-1161
e-mail: score@emmes.com


Publications of Results:
Other Publications:

Publications automatically indexed to this study:

Responsible Party: The EMMES Corporation
ClinicalTrials.gov Identifier: NCT00105027     History of Changes
Other Study ID Numbers: NEI-99, 5U10EY014351-05, 5U10EY014404, 5U10EY014352
Study First Received: March 3, 2005
Results First Received: November 9, 2010
Last Updated: July 9, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration