Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery

Study Overview
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Brief Summary
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The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous 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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Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts. Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of 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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Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery

Conditions
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Diabetic Macular Edema, Cataract

Intervention / Treatment
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* Drug: Lucentis


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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis injected Pre-operatively<br>Lucentis injected 2 weeks before cataract surgery | Drug: Lucentis<br>* Lucentis 0.5 MG Per 0.05 ML Injection<br>|
| Active Comparator: Lucentis injected intra-operatively<br>Lucentis injected during the course of the surgery by cataract surgeon. | Drug: Lucentis<br>* Lucentis 0.5 MG Per 0.05 ML Injection<br>|
| Experimental: Lucentis injected post-operatively<br>Lucentis injected 2 weeks after cataract surgery | Drug: Lucentis<br>* Lucentis 0.5 MG Per 0.05 ML Injection<br>|

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 , 6 months and 12 months after cataract surgery | 
| 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 , 6 months and 12 months after cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of postoperative injections | Total number of postoperative injections will be calculated | 12 months after cataract surgery | 
| percentage of patients with diabetic retinopathy progression | patients with diabetic retinopathy progression will be calculated | 12 months after cataract surgery |