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

S

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

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

Trial contacts and locations

1

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Central trial contact

wei shen; dongyan pan

Data sourced from clinicaltrials.gov

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