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Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium

Primary Purpose

Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pegaptanib sodium injection
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-Related Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects of either gender aged > or = to 50 years diagnosed with subfoveal neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion.
  2. Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart.
  3. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
  4. Provide written informed consent.
  5. Ability to return for all study visits.

Exclusion Criteria:

Subjects will not be eligible for the study if subjects cannot attend all study-required visits, or if any of the following criteria are present

  1. Unilateral ocular blunt trauma within one year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes.
  2. intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within one year of enrollment.
  3. Anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment.
  4. Glaucoma tube-shunt surgery
  5. Previous history of corneal transplant in the study or non-study eye
  6. Presence of vitreous macular traction
  7. Previous therapeutic radiation in the region of the study eye
  8. Any treatment with an investigational agent in the past 30 days for any condition
  9. Known serious allergies to the components of pegaptanib sodium formulation

Any of the following underlying diseases including:1. History or evidence of severe cardiac disease(e.g. NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment 7. History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 8. History or evidence of clinically significant impaired renal or hepatic function 8. Stroke (within 12 months of study entry) 9. Any major surgical procedure within one month of study entry 10. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity. Subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.

Sites / Locations

  • Marietta Eye Clinic
  • Wolfe Eye Clinic
  • Associates in Ophthalmology
  • Valley Retina Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal Injections of Macugen

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Endothelial Cell Density
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2011
Last Updated
January 6, 2021
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01573572
Brief Title
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Official Title
A Phase IV, Open Label, Multi-center Study to Assess the Effect of Intravitreal Injections of Macugen (Pegaptanib Sodium Injection) Administered Every 6 Weeks for 48 Weeks on the Corneal Endothelium.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 22, 2010 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Injections of Macugen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium injection
Other Intervention Name(s)
Macugen
Intervention Description
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Endothelial Cell Density
Description
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Time Frame
Baseline, Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects of either gender aged > or = to 50 years diagnosed with subfoveal neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion. Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. Provide written informed consent. Ability to return for all study visits. Exclusion Criteria: Subjects will not be eligible for the study if subjects cannot attend all study-required visits, or if any of the following criteria are present Unilateral ocular blunt trauma within one year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes. intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within one year of enrollment. Anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment. Glaucoma tube-shunt surgery Previous history of corneal transplant in the study or non-study eye Presence of vitreous macular traction Previous therapeutic radiation in the region of the study eye Any treatment with an investigational agent in the past 30 days for any condition Known serious allergies to the components of pegaptanib sodium formulation Any of the following underlying diseases including:1. History or evidence of severe cardiac disease(e.g. NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment 7. History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 8. History or evidence of clinically significant impaired renal or hepatic function 8. Stroke (within 12 months of study entry) 9. Any major surgical procedure within one month of study entry 10. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity. Subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandeep Kaur, M.D.
Organizational Affiliation
Valeant Pharmaceuticals NA
Official's Role
Study Director
Facility Information:
Facility Name
Marietta Eye Clinic
City
Murrieta
State/Province
California
ZIP/Postal Code
30060
Country
United States
Facility Name
Wolfe Eye Clinic
City
Marshalltown
State/Province
Iowa
ZIP/Postal Code
50158
Country
United States
Facility Name
Associates in Ophthalmology
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Valley Retina Institute
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States

12. IPD Sharing Statement

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Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium

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