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Titolo:
Photographic measures of cytomegalovirus retinitis as surrogates for visual outcomes in treated patients
Autore:
Holbrook, JT; Meinert, CL; Van Natta, ML; Davis, M; Hubbard, L; Jabs, DA;
Indirizzi:
Johns Hopkins Univ, Ctr Clin Trials, Baltimore, MD USA Johns Hopkins UnivBaltimore MD USA , Ctr Clin Trials, Baltimore, MD USA Johns Hopkins Univ, Dept Ophthalmol, Baltimore, MD USA Johns Hopkins UnivBaltimore MD USA , Dept Ophthalmol, Baltimore, MD USA Johns Hopkins Univ, Dept Med, Baltimore, MD USA Johns Hopkins Univ Baltimore MD USA ns Univ, Dept Med, Baltimore, MD USA Univ Wisconsin, Fundus Photograph Reading Ctr, Madison, WI USA Univ Wisconsin Madison WI USA us Photograph Reading Ctr, Madison, WI USA
Titolo Testata:
ARCHIVES OF OPHTHALMOLOGY
fascicolo: 4, volume: 119, anno: 2001,
pagine: 554 - 563
SICI:
0003-9950(200104)119:4<554:PMOCRA>2.0.ZU;2-M
Fonte:
ISI
Lingua:
ENG
Soggetto:
END-POINTS; CONTROLLED TRIAL; CLINICAL-TRIAL; GANCICLOVIR; AIDS; VALIDATION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
28
Recensione:
Indirizzi per estratti:
Indirizzo: Holbrook, JT 615 N Wolfe St,Room 5010, Baltimore, MD 21205 USA 615 N Wolfe St,Room 5010 Baltimore MD USA 21205 MD 21205 USA
Citazione:
J.T. Holbrook et al., "Photographic measures of cytomegalovirus retinitis as surrogates for visual outcomes in treated patients", ARCH OPHTH, 119(4), 2001, pp. 554-563

Abstract

Objective: To evaluate photographic measures of cytomegalovirus (CMV) retinitis as surrogate outcomes for changes in vision in patients with CMV retinitis related to the acquired immunodefiency syndrome. Methods: Data from 3 clinical trials of CMV retinitis treatments were analyzed. Two photographic assessments of retinitis in eyes involved at baseline were evaluated: progression (lesion border movement greater than or equalto 750 pm or occurrence of a new lesion) and change in area of retina involved with retinitis. Vision measures were decline in best-corrected visual acuity and change in visual field. Photographic measures were evaluated as surrogate outcomes based on 4 criteria: (1) association with vision measure; (2) ability to account for treatment-related differences in vision measure; (3) data completeness; and (4) sample size requirements. Results: Data from 1001 involved eyes (666 patients) were analyzed. Progression and change in area involved were predictive of declines in vision measures, accounted for 50% and 66% of the treatment effect on visual field, and were available from 93% and 64% of involved eyes, respectively. Sample size estimates for a clinical trial were smallest with progression as the design outcome. Conclusion: Progression and change in area involved met the first and second criteria for surrogate outcomes for visual field loss; a complete evaluation for visual acuity decline was not possible because treatment-related differences were not observed. Progression met the logistical and sample size criteria better than change in area of retina involved with retinitis.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 27/05/20 alle ore 15:40:14