Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Difficulty enrolling eligible subjects)
Sponsor:
Collaborator:
Eyetech Pharmaceuticals
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00346983
First received: June 29, 2006
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Cystoid Macular Edema
Drug: Pegaptanib sodium
Drug: Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Pegaptanib Sodium to Prevent Worsening of Cystoid Macular Edema Following Cataract Surgery in Diabetics

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]
  • Distribution of absolute levels of distance visual acuity at 18 weeks after cataract surgery [ Time Frame: 1 to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after cataract surgery [ Time Frame: pre-cataract surgery to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]
  • Analysis of decrease in retinal thickness by OCT at 18 weeks after cataract surgery [ Time Frame: pre-cataract surgery to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]
  • Analysis of level of diabetic retinopathy using recognized photographic grading system at 18 weeks after cataract surgery [ Time Frame: pre-cataract surgery to 18 weeks post-cataract surgery ] [ Designated as safety issue: No ]
  • Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry) [ Time Frame: pre-cataract surgery to 6 months post-cataract surgery ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pegaptanib sodium
0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections
Other Name: Macugen
Placebo Comparator: B Drug: Control
Sham injection, every 6 weeks, up to a total of 3 sham injections

Detailed Description:

Macular edema occurs as a complication of cataract surgery in approximately 2% of all surgeries. In this condition, cystic, fluid-filled spaces develop in the outer plexiform layer of the retina resulting in a loss of vision. This condition is termed "Cystoid Macular Edema (CME)." In non-diabetics, the majority of such cases resolve spontaneously.

Diabetic macular edema (DME) is an important cause of visual disability among patients with diabetes. It is widely recognized that cataract surgery often triggers severe CME in patients with pre-existing DME. This exacerbation begins immediately following cataract surgery; and unlike in non-diabetics the edema is likely to be protracted and poorly responsive both to traditional treatments for CME (topical NSAIDS) and DME (laser photocoagulation). Fluorescein angiography, a photographic test that evaluates the blood circulation in the back of the eye, has demonstrated that both CME and DME are associated with increased permeability of retinal blood vessels.

The high rates and severity of post-cataract surgery CME in diabetic patients with DME render this population ideal for the study of potential agents to reduce the rate and severity of this condition (i.e., post-cataract surgery CME). Recent studies have shown that vascular endothelial growth factor (VEGF) plays a major role in vessel permeability. Pegaptanib (Macugen) is an FDA-approved drug for wet AMD. Pegaptanib is a selective VEGF antagonist that blocks the effects of VEGF; therefore pegaptanib might decrease vessel permeability and possibly decrease the incidence and severity of CME. We plan to conduct a controlled pilot study to investigate the effects of pegaptanib (up to 3 treatments of pegaptanib given prior to cataract surgery and as often as every 6 weeks for up to 12 weeks after cataract surgery) in diabetic patients with pre-existing DME who are undergoing cataract surgery and who are, therefore, at very high risk for development of CME. Should the pilot study indicate a potential benefit of pegaptanib in this setting, a larger, fully powered clinical trial will be proposed. An effective treatment or preventive measure for post-cataract surgery macular edema in patients with diabetic retinopathy would offer benefit to a large patient population nationally that is at high risk of vision loss.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • Media opacity will not be an exclusion criterion provided that the investigator can assess the presence or absence of DME on OCT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346983

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Eyetech Pharmaceuticals
Investigators
Principal Investigator: Oliver D. Schein, MD, MPH, MBA The Johns Hopkins University School of Medicine
  More Information

No publications provided

Responsible Party: Oliver D. Schein, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00346983     History of Changes
Other Study ID Numbers: NA_00001385
Study First Received: June 29, 2006
Last Updated: May 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014