Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 2:47 AM
Study NCT ID:
NCT04067856
Status:
WITHDRAWN
Last Update Posted:
2021-02-21
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Study Overview
Official Title:
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to compare the effectiveness of bevacizumab (Avastin) with another a dexamethasone implant (Ozurdex), with respect to anatomic and visual outcomes as well as injection frequency in subjects undergoing cataract surgery with a concurrent diagnosis of diabetic macular edema (DME).
Detailed Description:
Subjects over the age of 18 with both: 1) visually significant cataracts requiring cataract surgery and 2) diabetic macular edema (DME) will be enrolled in the study. Subjects with high risk proliferative diabetic retinopathy and any other retinal vascular disease or retinal pathology that may limit vision will be excluded. Baseline photography will be done to quantify the amount of DME and to exclude the presence of proliferative diabetic retinopathy or other retinal vascular or general retinal pathology. Subjects will be randomized to receive either an intravitreal injection of Ozurdex or Avastin at the time of cataract surgery. Subjects will be monitored the day after surgery, one to two weeks after cataract surgery and again monthly thereafter for a total of six visits from the time of cataract surgery with standardized visual acuity measurement, ophthalmologic examination and retinal photography performed at each visit. For the first two months after cataract surgery, subjects receiving Ozurdex will receive an injection of Avastin if the degree of swelling worsens by more than 10% on photography or the vision decreases. For the first two months after cataract surgery, subjects receiving Avastin will receive repeat injections of Avastin on a monthly basis. For each monthly visit thereafter, both groups will receive an intravitreal injection of Avastin if clinically significant DME is present or if vision declines.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: