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Cataract DME - Peri vs. Intraop

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ClinicalTrials.gov Identifier: NCT03920878
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Hendrick, 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.

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

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 Name: 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 Name: EYELEA




Primary Outcome Measures :
  1. Change in best-corrected visual acuity (BCVA) [ Time Frame: 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 :
  1. Change in optical coherence tomography (OCT) central subfield (CSF) thickness [ Time Frame: 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.

  2. Total number of postoperative injections [ Time Frame: 6 months after cataract surgery ]
    Total number of postoperative injections will be calculated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920878


Contacts
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Contact: Andrew Hendrick, MD 404-778-7777 ahendrick@emory.edu

Locations
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United States, Georgia
Emory Clinic Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Andrew Hendrick, MD    404-778-7777    ahendrick@emory.edu   
Grady Health System Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Andrew Hendrick, MD    404-778-7777    ahendrick@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Andrew Hendrick, MD Emory University

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Responsible Party: Andrew Hendrick, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03920878     History of Changes
Other Study ID Numbers: IRB00106475
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.

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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

Keywords provided by Andrew Hendrick, Emory University:
anti-VEGF injections
pre-existing DME
cataract surgery

Additional relevant MeSH terms:
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Cataract
Macular Edema
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs