NCT00358423

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

7 months

First QC Date

July 27, 2006

Last Update Submit

May 8, 2008

Conditions

Cystoid Macular Edema

Keywords

CMEPegaptanibPost-Surgical Ocular Inflammation

Outcome Measures

Primary Outcomes (3)

  • 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

    18 weeks after enrollment

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

    18 weeks after enrollment

  • 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

    18 weeks after enrollment

Secondary Outcomes (3)

  • Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib

    18 weeks after enrollment

  • Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib

    18 weeks after enrollment

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

    6 months after enrollment

Study Arms (2)

A

EXPERIMENTAL
Drug: Pegaptanib Sodium

B

PLACEBO COMPARATOR
Drug: Control

Interventions

Pegaptanib SodiumDRUG

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

Also known as: Macugen
A
ControlDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Diana V. Do, MD

    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

July 27, 2006

First Posted

July 31, 2006

Study Start

July 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

US(1)