NCT04063358

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

Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Second Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Diabetic Macular Edema
• Cataract

Interventions

Type	Name	Description
DRUG	Lucentis	Lucentis 0.5 MG Per 0.05 ML Injection

Timeline

• Start date: 2019-08-22
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2019-08-21
• Last updated: 2020-03-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study