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Lucentis for Treatment of Macular Edema

NCT00464581 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2012-05-28

No results posted yet for this study

Summary

Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions. Over two million cataract extractions are performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an estimated 20,000-130,000 new cases of CME annually. Clinical CME historically was associated with visual acuity of 20/40 or worse with fluorescein angiographic evidence of macular edema in a classic petaloid pattern. Angiographic CME physiologically signals an inflammatory process causing distortion of the outer plexiform layer, which if not resolved quickly could result in non-repairable visual loss. Topical, periocular, or intravitreal corticosteroids, despite their associated side effects, are the mainstay for pharmacologic treatment for patients with CME. Their efficacy has never been demonstrated in a randomized, controlled and blinded study.

This is an open-label, Phase II study of intravitreally administered ranibizumab in subjects with cystoid macular edema secondary to non-ischemic retinopathy, as seen following cataract surgery with intraocular lens implantation.

Conditions

  • Cystoid Macular Edema

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Retina Institute of Hawaii

    lead OTHER

Principal Investigators

  • Michael D Bennett, MD · Retina Institute of Hawaii

Eligibility

Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00464581 on ClinicalTrials.gov