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The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema

This study has been terminated.
(Difficulty enrolling eligible subjects)
Sponsor:
Collaborator:
Eyetech Pharmaceuticals
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00358423
First received: July 27, 2006
Last updated: May 8, 2008
Last verified: May 2008
  Purpose

This research is being done to look at the effects of an experimental drug called pegaptanib (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that can occur after cataract surgery. Swelling in the retina can lead to blurry vision.

The only treatment available for this condition is eye drops that decrease swelling in the back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after 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 in Patients With Chronic, Post-Operative Cystoid Macular Edema

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Proportion of subjects improving >/= 15 letters (3 lines) of best-corrected distance visual acuity at 18 weeks after initiation of pegaptanib. Distribution of visual acuity changes at 18 weeks after initiation of pegaptanib [ Time Frame: 18 weeks after enrollment ] [ Designated as safety issue: No ]
  • Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib [ Time Frame: 18 weeks after enrollment ] [ Designated as safety issue: No ]
  • Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after initiation of pegaptanib using a 2-state stochastic model to account for events and recoveries from events [ Time Frame: 18 weeks after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib [ Time Frame: 18 weeks after enrollment ] [ Designated as safety issue: No ]
  • Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib [ Time Frame: 18 weeks after enrollment ] [ Designated as safety issue: No ]
  • Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pegaptanib Sodium
0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
Other Name: Macugen
Placebo Comparator: B Drug: Control
Sham injections, every 6 weeks, up to a total of 3 sham injections

Detailed Description:

While only 1% to 2% of people following cataract surgery develop visual acuity loss from chronic post-surgical cystoid macular edema (CME), this represents approximately 20,000 individuals in the U.S. each year, and many more throughout the world. No current drug or surgical treatment is very effective in the management of chronic post-surgical CME. Topical non-steroidal anti-inflammatory medications, such as ketorolac drops 4 times a day (qid) for 3 months, have been shown to reduce the extent of fluorescein leakage on angiography in patients with this condition; however, compliance can be difficult, not all cases resolve following this treatment, the drop is not approved for this indication, and it is unknown if this treatment has an effect that lasts beyond 3 to 6 months. The fluorescein angiographic findings and the effects of ketorolac drops suggest that the condition is a result of increased permeability from inflammation and might resolve with a therapy that decreases abnormal vessel permeability. 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 may decrease vessel permeability and possibly decrease CME. Pegaptanib has been shown to have some activity in reducing retinal blood vessel leakage in diabetic patients with chronic macular edema (Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-57.), further supporting the hypothesis that it might be effective in other causes of chronic macular edema. We plan to conduct a pilot study of the effects of pegaptanib (up to 3 treatments of pegaptanib given as often as every 6 weeks for up to 12 weeks) in subjects with chronic post-surgical CME. If pegaptanib treatment is shown to be beneficial for this condition, additional studies could be performed to prove long-term effectiveness in patients with chronic CME or even for prophylaxis for patients known to be at high risk of developing CME following ocular surgery.

  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)
  • Best corrected visual acuity < 20/40 but no worse than 20/800 in the study eye
  • Best corrected visual acuity better than or equal to 20/200 in the fellow eye
  • Post-surgical CME in the study eye as documented on OCT (central subfield >/= 250 microns)
  • 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.
  • Initiation of pegaptanib or sham injections may begin following at least 12 weeks of topical therapy for CME after cataract surgery or the other eye,if the best-corrected visual acuity has not improved by at least 5 letters and if the center point thickening on OCT has not improved by at least 20%. Patients who have been on topical ketorolac for greater than 12 weeks are still eligible for this study.

Exclusion Criteria:

  • History of intravitreal steroid (triamcinolone) injection into the study eye or fellow eye within 4 months prior to cataract surgery
  • CME due to other etiologies such as vein occlusion and diabetes.
  • Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole).
  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: NCT00358423

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Eyetech Pharmaceuticals
Investigators
Principal Investigator: Diana V. Do, MD The Johns Hopkins University School of Medicine
  More Information

No publications provided

Responsible Party: Diana V. Do, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00358423     History of Changes
Other Study ID Numbers: NA_00001702
Study First Received: July 27, 2006
Last Updated: May 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
CME
Pegaptanib
Post-Surgical Ocular Inflammation

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