Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics

NCT00346983 | Terminated Phase 1

• 1 other identifier: NA_00001385
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having cataract surgery.

Conditions

Cystoid Macular Edema

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects avoiding 15 letters (3 lines) of best-corrected distance visual acuity loss at 18 weeks after cataract surgery. Distribution of visual acuity changes at 18 weeks after cataract surgery

  1 to 18 weeks post-cataract surgery

• Distribution of absolute levels of distance visual acuity at 18 weeks after cataract surgery

  1 to 18 weeks post-cataract surgery

• Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after cataract surgery using a 2-state stochastic model to account for events and recoveries from events

  1 to 18 weeks post-cataract surgery

Secondary Outcomes (4)

• Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after cataract surgery

  pre-cataract surgery to 18 weeks post-cataract surgery

• Analysis of decrease in retinal thickness by OCT at 18 weeks after cataract surgery

  pre-cataract surgery to 18 weeks post-cataract surgery

• Analysis of level of diabetic retinopathy using recognized photographic grading system at 18 weeks after cataract surgery

  pre-cataract surgery to 18 weeks post-cataract surgery

• Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)

  pre-cataract surgery to 6 months post-cataract surgery

Study Arms (2)

A

EXPERIMENTAL

Drug: Pegaptanib sodium

B

PLACEBO COMPARATOR

Drug: Control

Interventions

Pegaptanib sodium DRUG

0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections

Also known as: Macugen

A

Control DRUG

Sham injection, every 6 weeks, up to a total of 3 sham injections

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (ages 18 years or older) with diabetes mellitus
• Best corrected visual acuity worse than 20/40 but no worse than 20/800 in the study eye
• Best corrected visual acuity better than or equal to 20/800 in the fellow eye
• DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery
• No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery
• Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed.

You may not qualify if:

• History of intravitreal steroid (triamcinolone) injection into the study eye within 4 months prior to cataract surgery
• Macular edema due to non-diabetic etiologies such as vein occlusion
• Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eyetech Pharmaceuticals: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Oliver D. Schein, MD, MPH, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 12, 2008

Record last verified: 2008-05

Locations

US (1)