Continuation of Previous Study to Gather More Data on Effect of Macugen on the Corneal Endothelium
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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. |
- 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: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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.
Contacts and Locations| Contact: Miguel Busquets, M.D. | 412-653-3080 | mbusquets@aioeyesurgeons.com |
| Contact: Michelle Colwell | 412-653-3080 ext 1041 | mcolwell@aioeyesurgeons.com |
| 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. | |
| Principal Investigator: | Miguel Busquets, M.D. | Associates in Ophthalmology |
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: | October 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Edema Macular Degeneration Macular Edema Retinal Vein Occlusion Signs and Symptoms Retinal Degeneration Retinal Diseases |
Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013