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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema; Cataract
• Intervention / Treatment: Drug: Lucentis

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 86-21
      • Recruiting
      • Changhai Hospital
      • Contact: dongyan pan; Phone Number: 86-21-31161995; Email: campus@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lucentis injected Pre-operatively; Lucentis injected 2 weeks before cataract surgery	Drug: Lucentis; Lucentis 0.5 MG Per 0.05 ML Injection
Active Comparator: Lucentis injected intra-operatively; Lucentis injected during the course of the surgery by cataract surgeon.	Drug: Lucentis; Lucentis 0.5 MG Per 0.05 ML Injection
Experimental: Lucentis injected post-operatively; Lucentis injected 2 weeks after cataract surgery	Drug: Lucentis; Lucentis 0.5 MG Per 0.05 ML Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month, 3 months , 6 months and 12 months after cataract surgery
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.	24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of postoperative injections	Total number of postoperative injections will be calculated	12 months after cataract surgery
percentage of patients with diabetic retinopathy progression	patients with diabetic retinopathy progression will be calculated	12 months after cataract surgery

Collaborators and Investigators

• Sponsor: Second Military Medical University
• Investigators: Principal Investigator: wei shen, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Lens Diseases; Macular Edema; Cataract; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: SecondMMU2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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