Abstract

The objective of this application is to evaluate the safety and efficacy of intravitreal injection(s) of triamcinolone acetonide in patients with macular edema. To accomplish this objective, a multicenter, randomized, controlled study comparing eyes with macular edema that receive intravitreal injection(s) of triamcinolone acetonide to eyes with macular edema that receive conventional therapy is proposed. Patient Population (inclusion criteria): -Macular edema secondary to diabetic retinopathy, central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). -Macular edema must involve the center of the fovea and area of macular edema must be equal to or greater than 0.44 disc area (area of central subfield of the ETDRS grid). -Eyes must have received at least one prior session of grid/focal photocoagulation prior to study entry (diabetic retinopathy and BRVO subgroups) and macular edema must have persisted for at least 90 days following treatment. Eyes with CRVO may be enrolled if macular edema persists for 90 days or more. -Visual acuity score of > 19 letters (20/400) and < 68 letters (20/50) by ETDRS visual acuity protocol in the study eye. Treatment vs. Control Groups: Eyes randomized to the treatment group will receive an intravitreal injection of triamcinolone acetonide (4mg/0.1 cc). Eyes randomized to the control group will be observed or treated with repeat grid/focal photocoagulation in the diabetic macular edema and BRVO subgroups and observed in the CRVO subgroup. Efficacy and Safety Assessments: The primary efficacy endpoint will be improvement by 10 or more letters from baseline in best-corrected visual acuity as determined by the ETDRS visual acuity protocol. Secondary efficacy outcomes will include area of retinal thickening and retinal thickness as assessed by stereoscopic fundus photography and optical coherence tomography. Potential adverse events such as endophthalmitis, retinal detachment, vitreous hemorrhage, cataract and glaucoma will be monitored with respect to frequency and severity.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY014351-02
Application #
6752820
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Redford, Maryann
Project Start
2003-06-01
Project End
2008-04-30
Budget Start
2004-05-01
Budget End
2005-04-30
Support Year
2
Fiscal Year
2004
Total Cost
$3,554,869
Indirect Cost

  Institution

Name
University of Wisconsin Madison
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715

  Publications

Aref, Ahmad A; Scott, Ingrid U; Oden, Neal L et al. (2015) Incidence, Risk Factors, and Timing of Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Injection for Macular Edema Secondary to Retinal Vein Occlusion: SCORE Study Report 15. JAMA Ophthalmol 133:1022-9
Weinberg, David V; Wahle, Aimee E; Ip, Michael S et al. (2013) Score Study Report 12: Development of venous collaterals in the Score Study. Retina 33:287-95
Scott, Ingrid U; Vanveldhuisen, Paul C; Oden, Neal L et al. (2012) Baseline characteristics and response to treatment of participants with hemiretinal compared with branch retinal or central retinal vein occlusion in the standard care vs corticosteroid for retinal vein occlusion (SCORE) study: SCORE study report 14. Arch Ophthalmol 130:1517-24
Chan, Clement K; Ip, Michael S; Vanveldhuisen, Paul C et al. (2011) SCORE Study report #11: incidences of neovascular events in eyes with retinal vein occlusion. Ophthalmology 118:1364-72
Scott, Ingrid U; VanVeldhuisen, Paul C; Oden, Neal L et al. (2011) 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 118:345-52
Oden, Neal; Vanveldhuisen, Paul C; Scott, Ingrid U et al. (2010) SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means. Drug Inf J 44:405-420
Blodi, Barbara A; Domalpally, Amitha; Scott, Ingrid U et al. (2010) 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 128:1140-5
Ip, Michael S; Scott, Ingrid U; VanVeldhuisen, Paul C et al. (2009) A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlus Arch Ophthalmol 127:1101-14
Domalpally, Amitha; Blodi, Barbara A; Scott, Ingrid U et al. (2009) The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study system for evaluation of optical coherence tomograms: SCORE study report 4. Arch Ophthalmol 127:1461-7
Ip, Michael S; Oden, Neal L; Scott, Ingrid U et al. (2009) SCORE Study report 3: study design and baseline characteristics. Ophthalmology 116:1770-1777.e1

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