Cataract DME - Peri vs. Intraop

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03920878
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept injected Pre- and Post-operatively — DRUG
    Three injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness).
  • Aflibercept injected intraoperatively — DRUG
    Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.

Study Details

Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Key Dates

Start date
May 31, 2020
Status verified
Dec 2020
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept injected Pre- and Post-operatively
    Pre- and Post-operative time of Aflibercept injections
  • Active Comparator: Aflibercept injected intraoperatively
    Intraoperative time of Aflibercept injection

Primary Outcome Measure

Change in best-corrected visual acuity (BCVA) [ Time Frame: 1 month, 3 months and 6 months after cataract surgery ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30322-
Grady Health SystemAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Emory Clinic· Atlanta, GAGrady Health System· Atlanta, GA

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