Cataract DME - Peri vs. Intraop

Phase 2

Withdrawn

• Conditions: Diabetic Macular Edema; Cataract
• Interventions: Drug: Aflibercept injected Pre- and Post-operatively; Drug: Aflibercept injected intraoperatively

• Registration Number: NCT03920878
• Lead Sponsor: Emory University

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Study Start: 2020-05
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept injected Pre- and Post-operatively	Aflibercept injected Pre- and Post-operatively	Pre- and Post-operative time of Aflibercept injections
Aflibercept injected intraoperatively	Aflibercept injected intraoperatively	Intraoperative time of Aflibercept injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States