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

Second Military Medical University

Status and phase: Unknown; Phase 3

Conditions: Cataract; Diabetic Macular Edema

Treatments: Drug: Lucentis

Study type: Interventional

Funder types: Other

Identifiers

NCT04063358

SecondMMU2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Lucentis injected Pre-operatively

Experimental group

Description:

Lucentis injected 2 weeks before cataract surgery

Treatment:

Drug: Lucentis

Lucentis injected intra-operatively

Active Comparator group

Description:

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

Treatment:

Drug: Lucentis

Lucentis injected post-operatively

Experimental group

Description:

Lucentis injected 2 weeks after cataract surgery

Treatment:

Drug: Lucentis