Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Valeant Pharmaceuticals International, Inc.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01573572
First received: February 4, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Retinal Vein Occlusion
Diabetic Macular Edema
Drug: pegaptanib sodium injection
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • No evidence of adverse effects on the corneal endothelium confirmed by specular microscopy [ Time Frame: 1 year minimum ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 125
Study Start Date: April 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573572

Contacts
Contact: Denise Raimondo 908 927-1885 denise.raimondo@valeant.com

Locations
United States, California
Marietta Eye Clinic Recruiting
Marietta, California, United States, 30060
Contact: Lakshmana Kooragayala    770-427-8111    lkooragayala@mariettaeye.com   
Contact: Stacey Andelman    678-472-3621    sandelman@mariettaeye.com   
Principal Investigator: Lakshmana Kooragayala         
United States, Iowa
Wolfe Eye Clinic Recruiting
Marshalltown, Iowa, United States, 50158
Contact: Charles Barnes    319-362-8032    cbarnes@wolfeclinic.com   
Contact: Susan Hallock    800-542-7956    shallock@wolfeclinic.com   
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    mbusquets@aioeyesurgeons.com   
Contact: Michelle Colwell    412-653-3080 ext 1041    mcolwell@aioeyesurgeons.com   
Principal Investigator: Miguel Busquets, M.D.         
United States, Texas
Valley Retina Institute Recruiting
Harlingen, Texas, United States, 78550
Contact: Victor Gonzalez    956-423-2100    research@vritx.com   
Contact: Gabriela Zavala    956-423-2100 ext 168    gzavala@vritx.com   
Principal Investigator: Victor Gonzalez, M.D.         
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Mandeep Kaur, M.D. Valeant Pharmaceuticals NA
  More Information

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01573572     History of Changes
Other Study ID Numbers: EOP 1024
Study First Received: February 4, 2011
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014