Cataract DME - Peri vs. Intraop

Sponsor

Emory University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03920878

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema Cataract	Drug: Aflibercept injected Pre- and Post-operatively Drug: Aflibercept injected intraoperatively	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in optical coherence tomography (OCT) central subfield (CSF) thickness [24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery]
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.
Total number of postoperative injections [6 months after cataract surgery]
Total number of postoperative injections will be calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory Clinic	Atlanta	Georgia	United States	30322
2	Grady Health System	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator: Andrew Hendrick, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrew Hendrick, Principal Investigator, Emory University

ClinicalTrials.gov Identifier:

NCT03920878

Other Study ID Numbers:

IRB00106475

First Posted:

Apr 19, 2019

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Andrew Hendrick, Principal Investigator, Emory University

anti-VEGF injections

pre-existing DME

cataract surgery

Additional relevant MeSH terms:

Cataract

Macular Edema

Aflibercept

Study Results

No Results Posted as of Dec 24, 2020