Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept

Conditions

• Irvine-Gass Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept — DRUG
  Subconjunctival aflibercept

Study Details

This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops). Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or years after cataract surgery and typically results in decreased vision. Subconjunctival injections are injections placed just beneath the clear membrane (conjunctiva) of the eye. A recent report of one patient who received two subconjunctival injections of a similar medication to the one being studied here indicated that subconjunctival injections of this class of medication may be an effective and less invasive alternative to intravitreal injections for pseudophakic CME. Because of the similarity of the drugs and the patient's treatment success, we would like to see if subconjunctival injection(s) of aflibercept will work in treating pseudophakic CME. If successful, the risk of an intraocular infection and glaucoma that comes with standard of care treatments might be greatly reduced.

Key Dates

Start date

Feb 22, 2019

Status verified

Oct 2024

Primary completion

Aug 18, 2019

Completion

Jan 2, 2020

Study Design

Enrollment

1 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Subconjunctival aflibercept
  Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.

Primary Outcome Measure

Adverse Events [ Time Frame: Month 2 ]

Locations (1)

Find similar trials in Boston, MA