Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00105027
Other study ID # NEI-99
Secondary ID 5U10EY014351-055
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date February 2009

Study information

Verified date May 2018
Source The EMMES Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).


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.


Recruitment information / eligibility

Status Completed
Enrollment 682
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).

- Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.

Study Design


Intervention

Other:
Standard Care
CRVO: observation; BRVO: standard care
Drug:
intravitreal triamcinolone injection
1 mg dose
intravitreal triamcinolone injection
4 mg

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
The EMMES Corporation Allergan, National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Blodi BA, Domalpally A, Scott IU, Ip MS, Oden NL, Elledge J, Warren K, Altaweel MM, Kim JE, Van Veldhuisen PC; SCORE Study Research Group. Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study system for evaluation of stereoscopic color fundus photographs and fluorescein angiograms: SCORE Study Report 9. Arch Ophthalmol. 2010 Sep;128(9):1140-5. doi: 10.1001/archophthalmol.2010.193. — View Citation

Chan CK, Ip MS, Vanveldhuisen PC, Oden NL, Scott IU, Tolentino MJ, Blodi BA; SCORE Study Investigator Group. SCORE Study report #11: incidences of neovascular events in eyes with retinal vein occlusion. Ophthalmology. 2011 Jul;118(7):1364-72. doi: 10.1016/j.ophtha.2010.11.020. Epub 2011 Mar 26. — View Citation

Domalpally A, Blodi BA, Scott IU, Ip MS, Oden NL, Lauer AK, VanVeldhuisen PC; SCORE Study Investigator Group. The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study system for evaluation of optical coherence tomograms: SCORE study report 4. Arch Ophthalmol. 2009 Nov;127(11):1461-7. doi: 10.1001/archophthalmol.2009.277. — View Citation

Domalpally A, Peng Q, Danis R, Blodi B, Scott IU, Ip M; SCORE Study Research Group. Association of outer retinal layer morphology with visual acuity in patients with retinal vein occlusion: SCORE Study Report 13. Eye (Lond). 2012 Jul;26(7):919-24. doi: 10.1038/eye.2012.59. Epub 2012 Apr 27. — View Citation

Ip MS, Oden NL, Scott IU, VanVeldhuisen PC, Blodi BA, Figueroa M, Antoszyk A, Elman M; SCORE Study Investigator Group. SCORE Study report 3: study design and baseline characteristics. Ophthalmology. 2009 Sep;116(9):1770-1777.e1. doi: 10.1016/j.ophtha.2009.03.022. Epub 2009 Jul 19. — View Citation

Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat visio — View Citation

Oden N, Vanveldhuisen PC, Scott IU, Ip MS; the SCORE Study Investigator Group. SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means. Drug Inf J. 2010 Jul 1;44(4):405-420. — View Citation

Scott IU, Blodi BA, Ip MS, Vanveldhuisen PC, Oden NL, Chan CK, Gonzalez V; SCORE Study Investigator Group. SCORE Study Report 2: Interobserver agreement between investigator and reading center classification of retinal vein occlusion type. Ophthalmology. 2009 Apr;116(4):756-61. doi: 10.1016/j.ophtha.2008.11.015. — View Citation

Scott IU, Ip MS, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Chan CK, Gonzalez VH, Singerman LJ, Tolentino M; SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vis — View Citation

Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Antoszyk AN; SCORE Study Investigator Group. SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol. 2009 Nov;148(5):725-732.e7. doi: 10.1016/j.ajo.2009.06.004. Epub 2009 Aug 11. — View Citation

Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA, Hartnett ME, Cohen G; Standard Care versus COrticosteroid for REtinal Vein Occlusion Study Investigator Group. Baseline predictors of visual acuity and retinal thickness outcomes in patients with retinal vein occlusion: Standard Care Versus COrticosteroid for REtinal Vein Occlusion Study report 10. Ophthalmology. 2011 Feb;118(2):345-52. doi: 10.1016/j.ophtha.2010.06.034. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
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. Change from baseline to 12 months
Secondary Changes From Baseline in Best-corrected ETDRS Visual Acuity Score 12 months
Secondary Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography 12 months
Secondary Adverse Ocular Outcomes 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Completed NCT04592419 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) Phase 3
Recruiting NCT05133791 - NIR Fluorescence Molecular Imaging of ANXV-800CW in RVO Patients Phase 1
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A
Completed NCT02898480 - Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning N/A
Recruiting NCT01581151 - Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion N/A
Completed NCT01428388 - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion N/A
Completed NCT00970957 - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion Phase 3
Recruiting NCT04075695 - Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
Recruiting NCT03525132 - Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV) N/A
Recruiting NCT03762226 - Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
Recruiting NCT02257333 - Retinal Thrombosis and Atherosclerosis
Recruiting NCT04140448 - Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion
Active, not recruiting NCT05003258 - Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection N/A
Terminated NCT04707625 - Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment Phase 4
Recruiting NCT04142164 - Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections N/A
Completed NCT02523339 - Study of Retinal Oxygenation in Central Retinal Vein Occlusion
Active, not recruiting NCT01449682 - Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections. Phase 3
Completed NCT01568021 - Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO) N/A
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1

External Links