May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
A Double-Masked, Randomized, Placebo-Controlled, Dose-Escalating Study of a Single Intravitreal Injection of INS37217 in Subjects with Retinal Detachment
Author Affiliations & Notes
  • P.E. Tornambe
    Retina Consultants, San Diego, Poway, CA, United States
  • G.M. Fox
    Retina Associates, Kansas City, MO, United States
  • L.S. Poliner
    Retina Associates, Kansas City, MO, United States
  • B.J. King
    Retina Associates, Kansas City, MO, United States
  • R.S. Whitsell
    Inspire Pharmaceuticals, Inc., Durham, NC, United States
  • L.M. LaVange
    Inspire Pharmaceuticals, Inc., Durham, NC, United States
  • D.J. Kellerman
    Inspire Pharmaceuticals, Inc., Durham, NC, United States
  • W.M. Peterson
    Inspire Pharmaceuticals, Inc., Durham, NC, United States
  • Footnotes
    Commercial Relationships  P.E. Tornambe, Retina Consultants, San Diego F; G.M. Fox, Retina Associates F; L.S. Poliner, Retina Consultants, San Diego F; B.J. King, Retina Associates F; R.S. Whitsell, Inspire Pharmaceuticals, Inc. E; L.M. LaVange, Inspire Pharmaceuticals, Inc E; D.J. Kellerman, Inspire Pharmaceuticals, Inc. E; W.M. Peterson, Inspire Pharmaceuticals, Inc. E.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 2027. doi:
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      P.E. Tornambe, G.M. Fox, L.S. Poliner, B.J. King, R.S. Whitsell, L.M. LaVange, D.J. Kellerman, W.M. Peterson; A Double-Masked, Randomized, Placebo-Controlled, Dose-Escalating Study of a Single Intravitreal Injection of INS37217 in Subjects with Retinal Detachment . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2027.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Abstract: : Purpose: To evaluate the efficacy and tolerability of INS37217 Intravitreal Injection, a P2Y2 receptor agonist, vs. placebo in stimulating retinal re-attachment without surgery in subjects presenting with a superior rhegmatogenous retinal detachment (RRD). Methods: Following a thorough screening exam and informed consent, eligible subjects presenting with a superior RRD otherwise amenable for treatment with pneumatic retinopexy (PR) were randomized to receive either a single intravitreal (IVT) injection of INS37217 (0.12, 0.24, or 0.48 mg/eye) or BSS (placebo) in lieu of PR. Extent of the RRD was evaluated using fundus examination and B-scan ultrasound at pretreatment and at 4 hr and 20-24 hr following treatment. At 24 hr following administration of INS37217 or BSS, patients requiring rescue treatment were treated with PR. Patients whose retina were sufficiently re-attached such that they did not require PR rescue therapy were treated with cryo or laser to repair the retinal tear(s). Ocular tolerability assessments were made at the following times after administration of drug or placebo: 1 and 5 min; 4 and 20-24 hr; 2, 7, 14, and 28 days; 2, 3, 6 and 12 months. Results: A total of 14 subjects were dosed (11 INS37217 and 3 BSS). At 20-24 hr post-administration subjects dosed with INS37217 Intravitreal Injection showed improvement in the extent of retinal re-attachment as measured by B-scan ultrasound and by fundus evaluation of the clock hours of detachment. Subjects dosed with BSS showed either no change or slight increase in the extent of retinal detachment. To date, no serious adverse events thought by the investigator to be related to study drug, have been reported. Conclusions: Intravitreal injection of INS37217, but not BSS, improved the extent of retinal re-attachment at 24 hr post administration. INS37217 was well-tolerated and a larger Phase 2 study is planned for the use of INS37217 as a surgical adjunct in retinal re-attachment surgery.

Keywords: clinical (human) or epidemiologic studies: tre • retinal development • retinal pigment epithelium 
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