Cataract DME - Peri vs. Intraop

Study Overview
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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.

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

Conditions
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Diabetic Macular Edema, Cataract

Intervention / Treatment
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* Drug: Aflibercept injected Pre- and Post-operatively
* Drug: Aflibercept injected intraoperatively


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-VEGF injections, pre-existing DME, cataract surgery