Intravitreal Aflibercept Injections In The Treatment Of Pattern Dystrophy (AVA)

Use Of Intravitreal Aflibercept Injections In The Treatment Of Adult-Onset Vitelliform Detachments Associated With Pattern Dystrophy

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.

Study Overview

• Status: Withdrawn
• Conditions: Pattern Dystrophy of Macula
• Intervention / Treatment: Drug: aflibercept

Detailed Description

Subretinal fluid is thought to play a role in the formation of vitelliform detachments, which are associated with progressive vision loss. Fluid in the subretinal space disrupts the physical apposition between photoreceptor outer segments and retinal pigment epithelial cells, which may in turn hinder the phagocytosis of shed photoreceptor outer segments. Material derived from the unphagocytized outer segments may accumulate in the subretinal space to form vitelliform lesions, resulting in a persistent detachment. Anti-VEGF therapy in the form of intravitreal aflibercept injections may be useful in controlling or eliminating subretinal fluid, thus promoting contact between photoreceptor outer segments and the retinal pigment epithelium. Vitelliform detachments may resolve subsequent to the removal of subretinal fluid and restoration of contact-dependent mechanisms of photoreceptor outer segment recycling.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Ns/Lij Meeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eyelea, ophthalmic exam, photgraphy; 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; 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; Other Names: eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• The incidence and severity of systemic and ocular adverse events.	0 - 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
• Anatomic reduction or resolution of vitelliform as determined by change on OCT, FA, fundus photos, and autofluoresence	6 months

Collaborators and Investigators

• Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Lawrence A. Yannuzzi, M.D., Northshore Long Island Jewish Healthcare Systems

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: AVA Study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: The AVA Study