Cataract DME - Peri vs. Intraop

Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Macular Edema; Cataract
• Intervention / Treatment: Drug: Aflibercept injected Pre- and Post-operatively; Drug: Aflibercept injected intraoperatively

Detailed Description

Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery

Exclusion Criteria:

• Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
• Patients with history of vitrectomy.
• Patients with neovascular glaucoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept injected Pre- and Post-operatively; Pre- and Post-operative time of Aflibercept injections	Drug: Aflibercept injected Pre- and Post-operatively; 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).; Other Names: EYELEA
Active Comparator: Aflibercept injected intraoperatively; Intraoperative time of Aflibercept injection	Drug: Aflibercept injected intraoperatively; Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.; Other Names: EYELEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best-corrected visual acuity (BCVA)	BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.	1 month, 3 months and 6 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in optical coherence tomography (OCT) central subfield (CSF) thickness	Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.	24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery
Total number of postoperative injections	Total number of postoperative injections will be calculated	6 months after cataract surgery

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Andrew Hendrick, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: cataract surgery; anti-VEGF injections; pre-existing DME
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Lens Diseases; Macular Edema; Cataract; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: IRB00106475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No