search
Back to results

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

Primary Purpose

Cystoid Macular Edema

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pegaptanib Sodium
Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystoid Macular Edema focused on measuring CME, Pegaptanib, Post-Surgical Ocular Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

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
Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib
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

Secondary Outcome Measures

Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)

Full Information

First Posted
July 27, 2006
Last Updated
May 8, 2008
Sponsor
Johns Hopkins University
Collaborators
Eyetech Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00358423
Brief Title
The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema
Official Title
Pilot Study of the Effect of Pegaptanib Sodium in Patients With Chronic, Post-Operative Cystoid Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Difficulty enrolling eligible subjects
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University
Collaborators
Eyetech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystoid Macular Edema
Keywords
CME, Pegaptanib, Post-Surgical Ocular Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pegaptanib Sodium
Other Intervention Name(s)
Macugen
Intervention Description
0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Sham injections, every 6 weeks, up to a total of 3 sham injections
Primary Outcome Measure Information:
Title
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
Title
Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib
Time Frame
18 weeks after enrollment
Title
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
Secondary Outcome Measure Information:
Title
Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib
Time Frame
18 weeks after enrollment
Title
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib
Time Frame
18 weeks after enrollment
Title
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana V. Do, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs