National Conference on Human Retroviruses and Related Infections.
Program Abstr Second Natl Conf Hum Retrovir Relat Infect Natl Conf Hum Retrovir Relat Infect 2nd 1995 Wash DC. 1995 Jan 29-Feb 2; 170.
Chiron Vision Corporation, Irvine, CA.
A randomized, controlled multicenter clinical trial was conducted to evaluate the safety and efficacy of a sustained release intraocular ganciclovir implant (GCV implant), as compared to standard intravenous ganciclovir therapy (IVG). Patients were assigned to receive treatment with either a 1 microgram/hr or 2 micrograms/hr implant or IVG and were followed to progression of retinitis or death. Progression of retinitis was defined by movement of retinitis borders by greater than or equal to 750 m or development of a new lesion, and was determined by a central masked Fundus Photograph Reading Center (FPRC) at the University of Wisconsin. A planned interim analysis was conducted following completion of patient enrollment, and included data from 148/188 patients. The median time to progression for patients in the IVG group, as evaluated by the FPRC, was 72 days versus 150 days in the combined implant group (p less than 0.0001, log rank test). For treated eyes with retinitis at baseline, the medians were 88 and 202 days, respectively. Our ability to compare implant and IVG treatment with respect to manifestations of extraocular CMV or retinitis in initially uninvolved eyes was limited, since patients in the IVG arm of the study were offered an implant when progression occurred. However, there was no statistically significant difference between the IVG group and the combined implant groups with respect to manifestations of extraocular CMV (p=0.060, log rank test) or retinitis in initially uninvolved eyes (p=0.517, log rank test). There were few reported adverse events. These results demonstrate that the GCV implant represents a clinically important improvement over intravenous ganciclovir in delaying the progression of retinitis.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Cytomegalovirus Retinitis
- Disease Progression
- Double-Blind Method
- Fundus Oculi
- Ganciclovir
- Humans
- Randomized Controlled Trials as Topic
- Research Design
- Retinitis
- Wisconsin
- methods
Other ID:
UI: 102213599
From Meeting Abstracts