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MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency in syndrome - The monoclonal antibody cytomegalovirus retinitis trial

Lewis, RA; CarrHolden, LM; Doyle, K; Fainstein, V; Gardner, N; Gross, R; OrengoNania, S; Patel, V; Samo, TC; Shigley, JW; Shawver, L; Spencer, SS; Weinert, M; Martin, DF; Gibbs, D; Jernigan, J; Dunn, JP; Bartlett, J; Becker, R; Jabs, DA; Johnson, DA; LaSalvia, S; Leslie, J; Maenza, J; Miller, T; Neisser, LG; Semba, RD; Tucker, P; Barron, B; Jarrott, C; Peyman, G; Swenie, D; Heinemann, MH; Janis, R; Polsky, B; Sepkowitz, K; Friedman, AH; Ginsburg, R; Severin, C; Teich, S; Wallach, F; Rescigno, R; PaezBoham, R; Buroff, E; Kloser, P; Wanner, M; Friedberg, DN; Addessi, A; Chachoua, A; Dieterich, D; Hill, J; Hutt, R; Kaul, A; Ligh, J; LorenzoLatkany, M; Pei, M; Powers, T; Weinberg, DV; Jampol, EM; Lyon, AT; Munana, A; Murphy, R; Palella, F; Richine, L; Strugala, Z; Valadez, G; Holland, GN; Carlson, ME; Chafey, SA; Hardy, WD; Johiro, AK; MacArthurChang, LJ; Martin, MA; Moe, AA; Strong, CA; Tufail, A; Ugalat, PS; Weisz, JM; Freeman, WR; ArevaloColina, JF; Clark, T; Jarman, CL; Meixner, L; Meng, TC; Spector, S; Taskintuna, I; Torriani, FJ; ODonnell, J; Alfred, P; Ballesteros, F; Clay, D; Coleman, R; Gordon, K; Gumbley, D; Hoffman, J; Irvine, A; Jacobson, M; Larson, M; Macalalag, L; Narahara, M; Payne, M; Seiff, S; Wilson, S; Woodring, H; Davis, J; Blenke, A; Madera, I; Mendez, P; Murray, T; vanderHorst, C; Kylstra, J; Wohl, D; Ziman, K; Pavan, PR; Grizzard, WS; Bergen, GA; Cohen, SM; Craig, JA; Dehler, RL; Elbert, E; Fox, RW; Hammer, ME; Hernandez, LS; Herrera, S; Holt, D; Kemp, S; Larkin, JA; Ledford, DK; Lockey, RF; Menosky, MM; Millard, S; Nadler, JP; Nelson, RP; Norris, D; Ormerod, LD; Pautler, SE; Poblete, SJ; Rodriguez, D; Rosenbach, KP; Seekins, DW; Toney, JR; Dodge, JM; Klemstine, JL; Schuerholtz, TA; Stevens, M; Meinert, CL; AmendLibercci, D; Coleson, L; Collins, KL; Collison, BJ; Dawson, C; Dodge, J; Donithan, M; Ewing, C; Fink, N; Gerczak, C; Harle, J; Holbrook, JT; Huffman, R; Isaacson, MR; Gilpin, AMK; Lane, M; Levine, CR; Martin, B; Meinert, J; Min, N; Nowakowski, DJ; Owens, RM; Oziemkowska, MJ; Piantadosi, B; Saah, A; Smith, M; Tonascia, J; VanNatta, ML; Davis, MD; Armstrong, J; Brickbauer, J; Brothers, R; Chop, M; Hubbard, L; Hurlburt, D; Kastorff, L; Neider, M; Onofrey, J; Stoppenbach, V; VanderhoofYoung, M; Walls, M; Hughes, R; Kurinij, N; Mowery, RL; Alston, B; Foulkes, M; Nadler, PI; Wood, DL; Bladet, M; Wu, N; Clark, T; Feinberg, J; Freeman, W; Holbrook, J; McArthurChang, L; Duncan, WR; Kessler, H; Lambert, AG; Powderly, W; Schnittman, S; Spector, S; Brown, BW; Conway, B; Grizzle, J; Nussenblatt, R; Phair, JP; Smith, H; Whitley, R; Cheng, B; Frost, K; Marco, M
Objective: To evaluate the the efficacy and safety of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. Methods: Two hundred nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo-controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60 mg intravenously every 2 weeks, or placebo. Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician. Results: The rates of retinitis progression, as evaluated in a masked fashion, were 3.04/person-year in the MSL-109-treated group and 3.05/person-year in the placebo-treated group (P=.98; Wald test); the median times to progression were 67 days in the MSL-109-treated group and 65 days in the placebo-treated group. No differences between the 2 groups were noted in the rates of increase in retinal area involved by CMV, visual field loss, or visual acuity outcomes. The mortality rate in the MSL-109-treated group was 0.68/person-year, and in the placebo-treated group, 0.31/person-year (P=.01). The mortality difference was not explained by differences in baseline variables or in concurrent antiretroviral therapy. Among patients with newly diagnosed retinitis, mortality rates were similar (MSL-109, 0.41/person-year; placebo, 0.42/person-year; P=.95), whereas among patients with relapsed retinitis the MSL-109-treated group had a greater mortality rate (MSL-109, 0.83/person-year, placebo, 0.24/person-year; P=.003). However, the mortality rate in the placebo-treated patients with relapsed CMV retinitis was lower than that in the placebo-treated patients with newly diagnosed CMV retinitis and lower than that in other trials of patients with relapsed CMV retinitis. Conclusions: Intravenous MSL-109, 60 mg every 2 weeks, appeared to be ineffective adjuvant therapy for CMV retinitis. The mortality rate was higher in the MSL-109-treated group, but the reasons for this difference remain uncertain
ISI:A1997YK25100005
ISSN: 0003-9950
CID: 53126

Exchange transfusion in sickling maculopathy [Case Report]

Khwarg SG; Feldman S; Ligh J; Straatsma BR
Unilateral macular infarction occurred in a 23-year-old black man with sickle cell hemoglobinopathy (SS), who was already receiving oxygen and hydration treatment for a painful crisis. Visual acuity of 20/200-1 in the affected eye did not improve with 36 hours of 'conservative' treatment. Fifteen hours after an exchange transfusion, however, visual acuity started to improve. By 36 hours after transfusion, a visual acuity of 20/40 was achieved, with the gradual return over 8 weeks to 20/20. This case provides strong circumstantial support for the effectiveness of exchange transfusion in sickling maculopathy
PMID: 3835617
ISSN: 0275-004x
CID: 26011

Physical properties of vitamin E oil and silicone oil

Yoshizumi MO; Dunn B; Ligh JK; Allman RM 3rd
A comparison of the physical properties of vitamin E oil and silicone oil is made. The parameters measured include: viscosity, fluid density, refractive index and wetting characteristics of the water/liquid interface. These properties showed remarkable similarities between vitamin E oil and silicone oil
PMID: 4070808
ISSN: 0275-004x
CID: 23094