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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2021-08-31

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.

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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.

Conditions

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Diabetic Macular Edema Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lucentis injected Pre-operatively

Lucentis injected 2 weeks before cataract surgery

Group Type EXPERIMENTAL

Lucentis

Intervention Type DRUG

Lucentis 0.5 MG Per 0.05 ML Injection

Lucentis injected intra-operatively

Lucentis injected during the course of the surgery by cataract surgeon.

Group Type ACTIVE_COMPARATOR

Lucentis

Intervention Type DRUG

Lucentis 0.5 MG Per 0.05 ML Injection

Lucentis injected post-operatively

Lucentis injected 2 weeks after cataract surgery

Group Type EXPERIMENTAL

Lucentis

Intervention Type DRUG

Lucentis 0.5 MG Per 0.05 ML Injection

Interventions

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Lucentis

Lucentis 0.5 MG Per 0.05 ML Injection

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No