Clinical Trial: Lucentis (Ranibizumab) for Eales' Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of a VEGF Inhibitor (Lucentis) in Refractory Macular Edema Due to Eales' Disease

Brief Summary: The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.

Detailed Summary: This is a six-month study. Eligible subjects will receive one injection of the study drug into one eye for each of three months. Visual acuity, blood pressure and eye pressure will be tested. Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT). Safety visits will be scheduled for the week after the injections. The investigators will monitor the subjects' eyes for infection and inflammation. After the three-month treatment period, subjects will return to the clinic monthly for four follow-up visits. Procedures and tests that will be performed at the follow-up visits include visual acuity, a retinal exam including OCT, blood pressure, and eye pressure.
Sponsor: Oregon Health and Science University

Current Primary Outcome:

  • Change in OCT thickness. [ Time Frame: 6 months ]
  • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing) [ Time Frame: Monthly ]
  • Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs [ Time Frame: Monthly ]


Original Primary Outcome:

  • Change in OCT thickness over the course of the study.
  • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
  • Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs


Current Secondary Outcome:

  • BCVA, as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters. [ Time Frame: Months 3,4,5 and 6 ]
  • Incidence of ocular and non-ocular adverse events evaluated through month 6. [ Time Frame: Monthly ]


Original Secondary Outcome:

  • BCVA, as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Months 3,4,5 and 6.
  • Incidence of ocular and non-ocular adverse events evaluated through month 6.


Information By: Oregon Health and Science University

Dates:
Date Received: October 5, 2006
Date Started: October 2006
Date Completion:
Last Updated: April 2, 2009
Last Verified: April 2009