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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Manhattan Eye, Ear & Throat Hospital
Sponsor:
Collaborator:
North Shore Long Island Jewish Health System
Information provided by (Responsible Party):
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT01965041
First received: October 11, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Pattern Dystrophy of Macula
Drug: aflibercept

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use Of Intravitreal Aflibercept Injections In The Treatment Of Adult-Onset Vitelliform Detachments Associated With Pattern Dystrophy

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:
  • • The incidence and severity of systemic and ocular adverse events. [ Time Frame: 0 - 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Anatomic reduction or resolution of vitelliform as determined by change on OCT, FA, fundus photos, and autofluoresence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: October 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: eylea

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965041

Locations
United States, New York
Ns/Lij Meeth Recruiting
New York, New York, United States, 10065
Contact: Lawrence A. Yannuzzi, M.D.    212-605-3777    layannuzzi@gmail.com   
Contact: Maria J. Scolaro, M.A.,C.O.T.    212-605-3777    mscolaro@nshs.edu   
Principal Investigator: Lawrence A. Yannuzzi, M.D.         
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Lawrence A. Yannuzzi, M.D. Northshore Long Island Jewish Healthcare Systems
  More Information

No publications provided

Responsible Party: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT01965041     History of Changes
Other Study ID Numbers: The AVA Study
Study First Received: October 11, 2013
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Manhattan Eye, Ear & Throat Hospital:
AVA Study

ClinicalTrials.gov processed this record on October 20, 2014