Intravitreal Aflibercept Injections In The Treatment Of Pattern Dystrophy

• Status: Withdrawn
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Adult-onset vitelliform detachments associated with pattern dystrophy is a genetic disorder that carries visual implications that most commonly affect the macula (area in the eye near the retina that is essential for sharp central vision). Adult onset vitelliform detachments have an accumulation of material on the outer retina. Over time, the abnormal accumulation of this material can damage cells that are critical for clear central vision. As a result, people with this disorder often lose their central vision, and their eyesight may become blurry or distorted.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborator: Northwell Health
• Treatments: Aflibercept

Criteria

Inclusion Criteria:A patient must meet the following criteria to be eligible for inclusion in the study:

1. Presence of adult onset vitelliform detachment associated with pattern dystrophy of at least one year duration 2. Treatment naive 3. Age >50 years old 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide signed informed consent

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Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

1. Previous treatment of adult onset vitelliform detachment associated with pattern dystrophy

2. Presence of any substantial ocular disease that may compromise or confound interpretation of the data

3. Active intraocular inflammation

4. Patients allergic to fluorescein, povidone iodine (Betadine) or aflibercept

5. Patients on systemic anti-VEGF agents within 3 months of study enrollment

6. Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study

7. Pregnant or breast-feeding women

8. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

• Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation