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Cataract DME - Peri vs. Intraop

NCT ID: NCT03920878

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Macular Edema Cataract

Keywords

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anti-VEGF injections pre-existing DME cataract surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aflibercept injected Pre- and Post-operatively

Pre- and Post-operative time of Aflibercept injections

Group Type EXPERIMENTAL

Aflibercept injected Pre- and Post-operatively

Intervention Type 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

Intraoperative time of Aflibercept injection

Group Type ACTIVE_COMPARATOR

Aflibercept injected intraoperatively

Intervention Type DRUG

Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.

Interventions

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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).

Intervention Type DRUG

Aflibercept injected intraoperatively

Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.

Intervention Type DRUG

Other Intervention Names

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EYELEA EYELEA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hendrick

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Hendrick, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Clinic

Atlanta, Georgia, United States

Site Status

Grady Health System

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00106475

Identifier Type: -

Identifier Source: org_study_id