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

Primary Purpose

Diabetic Macular Edema, Cataract

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lucentis
Sponsored by
Second Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Lucentis injected Pre-operatively

Lucentis injected intra-operatively

Lucentis injected post-operatively

Arm Description

Lucentis injected 2 weeks before cataract surgery

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

Lucentis injected 2 weeks after cataract surgery

Outcomes

Primary Outcome Measures

Change in best-corrected visual acuity (BCVA)
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.

Secondary Outcome Measures

Total number of postoperative injections
Total number of postoperative injections will be calculated
percentage of patients with diabetic retinopathy progression
patients with diabetic retinopathy progression will be calculated

Full Information

First Posted
August 19, 2019
Last Updated
March 25, 2020
Sponsor
Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04063358
Brief Title
Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
Acronym
Anti-VEGF
Official Title
Timing of Anti-vascular Endothelial Growth Factor(Anti-VEGF) Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lucentis injected Pre-operatively
Arm Type
Experimental
Arm Description
Lucentis injected 2 weeks before cataract surgery
Arm Title
Lucentis injected intra-operatively
Arm Type
Active Comparator
Arm Description
Lucentis injected during the course of the surgery by cataract surgeon.
Arm Title
Lucentis injected post-operatively
Arm Type
Experimental
Arm Description
Lucentis injected 2 weeks after cataract surgery
Intervention Type
Drug
Intervention Name(s)
Lucentis
Intervention Description
Lucentis 0.5 MG Per 0.05 ML Injection
Primary Outcome Measure Information:
Title
Change in best-corrected visual acuity (BCVA)
Description
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Time Frame
1 month, 3 months , 6 months and 12 months after cataract surgery
Title
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Description
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
Time Frame
24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery
Secondary Outcome Measure Information:
Title
Total number of postoperative injections
Description
Total number of postoperative injections will be calculated
Time Frame
12 months after cataract surgery
Title
percentage of patients with diabetic retinopathy progression
Description
patients with diabetic retinopathy progression will be calculated
Time Frame
12 months after cataract surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dongyan pan
Phone
86-21-31161995
Email
campus@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
wei shen
Phone
86-21-31161995
Email
shenwzz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei shen
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
86-21
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dongyan pan
Phone
86-21-31161995
Email
campus@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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