Lucentis for Treatment of Macular Edema

NCT00464581 | Completed

• 1 other identifier: FVF-4153s
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-ischemic retinopathy

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of ranibizumab in patients with CME secondary to non-ischemic retinopathy

  2 years

Secondary Outcomes (7)

• Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart, at each month of months 0-12.

  2 years

• Proportion of subjects who remained at baseline VA or gained >0 lines of vision from baseline to week 24 and 52.

  2 years

• Mean change in central retinal thickness on OCT 3 from Baseline to week 24 and 52.

  2 years

• Changes observed on the Fluoreosceiien Angiographs from baseline to week 24 and 52.

  2 years

• Mean number of ranibizumab injections required.

  2 years

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Macular Edema

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \< 90 years
• Cystoid macular edema, documented by FFA
• Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/30 and 20/800 in a Snellen chart.
• Women must be using two forms of effective contraception, be post¬menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.

You may not qualify if:

• Significant media opacities, which might interfere with visual acuity.
• Any ocular or periocular infection in the past 4 weeks.
• Presence of pigment epithelial tears or rips.
• Any of the following underlying diseases including:
• Diabetic retinopathy.
• History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment.
• History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
• History or evidence of clinically significant impaired renal or hepatic function
• Stroke (within 12 months of trial entry).
• Any major surgical procedure within one month of trial entry.
• Previous therapeutic radiation in the region of the study eye.
• Any treatment with an investigational agent in the past 30 days for any condition.
• Known serious allergies to the fluorescein dye used in angiography or to the components of ranibizumab formulation.

Sponsors & Collaborators

• Retina Institute of Hawaii: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Retina Institute of Hawaii

Honolulu, Hawaii, 96815, United States

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Michael D Bennett, MD

  Retina Institute of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (1)