Continuation of Previous Study to Gather More 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01573572
Recruitment Status : Recruiting
First Posted : April 9, 2012
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
Due to the lack of information generated in the pivotal phase III trials assessing potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium, the FDA requested clinical information from a 1-year (minimum) 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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 2010
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. No evidence of adverse effects on the corneal endothelium confirmed by specular microscopy [ Time Frame: 1 year minimum ]
    The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density loss from baseline over time and frequency distribution. 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01573572

Contact: Denise Raimondo 908 927-1885

United States, California
Marietta Eye Clinic Recruiting
Murrieta, California, United States, 30060
Contact: Lakshmana Kooragayala    770-427-8111   
Contact: Stacey Andelman    678-472-3621   
Principal Investigator: Lakshmana Kooragayala         
United States, Iowa
Wolfe Eye Clinic Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Charles Barnes    319-362-8032   
Contact: Susan Hallock    800-542-7956   
Principal Investigator: Charles Barnes         
United States, Pennsylvania
Associates in Ophthalmology Recruiting
West Mifflin, Pennsylvania, United States, 15122
Contact: Miguel Busquets, M.D.    412-653-3080   
Contact: Michelle Colwell    412-653-3080 ext 1041   
Principal Investigator: Miguel Busquets, M.D.         
United States, Texas
Valley Retina Institute Recruiting
Harlingen, Texas, United States, 78550
Contact: Victor Gonzalez    956-423-2100   
Contact: Gabriela Zavala    956-423-2100 ext 168   
Principal Investigator: Victor Gonzalez, M.D.         
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Mandeep Kaur, M.D. Valeant Pharmaceuticals NA

Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT01573572     History of Changes
Other Study ID Numbers: EOP 1024
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases