Viewing Study NCT04063358


Ignite Creation Date: 2025-12-25 @ 12:19 AM
Ignite Modification Date: 2025-12-27 @ 7:27 AM
Study NCT ID: NCT04063358
Status: UNKNOWN
Last Update Posted: 2020-03-26
First Post: 2019-08-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
Sponsor: Second Military Medical University
Organization:

Study Overview

Official Title: Timing of Anti-vascular Endothelial Growth Factor(Anti-VEGF) Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery
Status: UNKNOWN
Status Verified Date: 2020-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Anti-VEGF
Brief 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: