Intravitreal Aflibercept Injections In The Treatment Of Pattern Dystrophy

Conditions

• Pattern Dystrophy of Macula

Eligibility Criteria

Sex

ALL

Age

50 Years - 90 Years

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Oct 31, 2013

Status verified

Dec 2014

Primary completion

Nov 30, 2014

Completion

Nov 30, 2014

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

• The incidence and severity of systemic and ocular adverse events. [ Time Frame: 0 - 6 months ]

Locations (1)

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