Intravitreal Aflibercept Injections In The Treatment Of Pattern Dystrophy

NCT01965041 | Withdrawn DMC

• 1 other identifier: The AVA Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pattern Dystrophy of Macula

Keywords

AVA Study

Outcome Measures

Primary Outcomes (1)

• • The incidence and severity of systemic and ocular adverse events.

  0 - 6 months

Secondary Outcomes (1)

• • Anatomic reduction or resolution of vitelliform as determined by change on OCT, FA, fundus photos, and autofluoresence

  6 months

Study Arms (1)

Eyelea, ophthalmic exam, photgraphy

EXPERIMENTAL

2.0 mg intravitreal aflibercept injection is formulated as a sterile liquid to a final concentration of 40 mg/mL aflibercept in 5% sucrose, 10 mM sodium phosphate pH 6.3, 0.03% polysorbate 20, and 40 mM NaCl

Drug: aflibercept

Interventions

aflibercept DRUG

2.0 mg intravitreal aflibercept injection is formulated as a sterile liquid to a final concentration of 40 mg/mL aflibercept in 5% sucrose, 10 mM sodium phosphate pH 6.3, 0.03% polysorbate 20, and 40 mM NaClvs. placebo

Also known as: eylea

Eyelea, ophthalmic exam, photgraphy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from the study:
• Previous treatment of adult onset vitelliform detachment associated with pattern dystrophy
• Presence of any substantial ocular disease that may compromise or confound interpretation of the data
• Active intraocular inflammation
• Patients allergic to fluorescein, povidone iodine (Betadine) or aflibercept
• Patients on systemic anti-VEGF agents within 3 months of study enrollment
• Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
• Pregnant or breast-feeding women
• 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

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• Northwell Health: collaborator

Study Sites (1)

Ns/Lij Meeth

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Lawrence A. Yannuzzi, M.D.

  Northshore Long Island Jewish Healthcare Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (1)