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



Status:Active, not recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:11/28/2018
Start Date:April 2010
End Date:November 2020

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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.

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.


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.
We found this trial at
4
sites
Harlingen, Texas 78550
Principal Investigator: Victor Gonzalez, M.D.
Phone: 956-423-2100
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Marshalltown, Iowa 50158
Principal Investigator: Charles Barnes
Phone: 319-362-8032
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Marshalltown, IA
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Murrieta, California 30060
Principal Investigator: Lakshmana Kooragayala
Phone: 770-427-8111
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Murrieta, CA
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West Mifflin, Pennsylvania 15122
Principal Investigator: Miguel Busquets, M.D.
Phone: 412-653-3080
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West Mifflin, PA
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