Clinical trial NCT01573572: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Retinal Vein Occlusion
Diabetic Macular Edema
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 131
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Mean Endothelial Cell Density
timeFrame: Baseline, Week 54
Secondary outcomes:
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Marietta Eye Clinic
state: California
city: Marshalltown
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: West Mifflin
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: Harlingen
country: United States
facility: Valley Retina Institute
state: Texas
Study officials:
affiliation: Valeant Pharmaceuticals NA
name: Mandeep Kaur, M.D.
role: STUDY_DIRECTOR
References: