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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01573572
Recruitment Status : Completed
First Posted : April 9, 2012
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Retinal Vein Occlusion Diabetic Macular Edema Drug: pegaptanib sodium injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : April 22, 2010
Actual Primary Completion Date : November 14, 2019
Actual Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravitreal Injections of Macugen Drug: pegaptanib sodium injection
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Other Name: Macugen




Primary Outcome Measures :
  1. Change From Baseline in Mean Endothelial Cell Density [ Time Frame: Baseline, Week 54 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573572


Locations
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United States, California
Marietta Eye Clinic
Murrieta, California, United States, 30060
United States, Iowa
Wolfe Eye Clinic
Marshalltown, Iowa, United States, 50158
United States, Pennsylvania
Associates in Ophthalmology
West Mifflin, Pennsylvania, United States, 15122
United States, Texas
Valley Retina Institute
Harlingen, Texas, United States, 78550
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Mandeep Kaur, M.D. Valeant Pharmaceuticals NA
  Study Documents (Full-Text)

Documents provided by Bausch Health Americas, Inc.:
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01573572    
Other Study ID Numbers: EOP 1024
First Posted: April 9, 2012    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: October 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases