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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 Occlusion (SCORE) study report 5.

AbstractOBJECTIVE:
To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).
METHODS:
Multicenter, randomized, clinical trial of 271 participants.
MAIN OUTCOME MEASURE:
Gain in visual acuity letter score of 15 or more from baseline to month 12.
RESULTS:
Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.
CONCLUSIONS:
Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
AuthorsMichael S Ip, Ingrid U Scott, Paul C VanVeldhuisen, Neal L Oden, Barbara A Blodi, Marian Fisher, Lawrence J Singerman, Michael Tolentino, Clement K Chan, Victor H Gonzalez,
JournalArchives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 127 Issue 9 Pg. 1101-14 (Sep 2009) ISSN: 1538-3601 [Electronic] United States
PMID19752419 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Glucocorticoids
  • Triamcinolone Acetonide
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Fluorescein Angiography
  • Follow-Up Studies
  • Glucocorticoids (administration & dosage, adverse effects)
  • Humans
  • Injections
  • Macular Edema (diagnosis, drug therapy, etiology)
  • Male
  • Middle Aged
  • Observation
  • Prospective Studies
  • Retinal Vein Occlusion (complications, diagnosis, drug therapy)
  • Retreatment
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Triamcinolone Acetonide (administration & dosage, adverse effects)
  • Vision Disorders (diagnosis, drug therapy, etiology)
  • Visual Acuity (drug effects)
  • Vitreous Body

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