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

Sponsor

Second Military Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04063358

Collaborator

(none)

Enrollment

Location

Arms

24.3

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema Cataract	Drug: Lucentis	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 22, 2019

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in best-corrected visual acuity (BCVA) [1 month, 3 months , 6 months and 12 months after cataract surgery]
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 [24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery]
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 [12 months after cataract surgery]
Total number of postoperative injections will be calculated
percentage of patients with diabetic retinopathy progression [12 months after cataract surgery]
patients with diabetic retinopathy progression will be calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital	Shanghai	Shanghai	China	86-21

Sponsors and Collaborators

Second Military Medical University

Investigators

Principal Investigator: wei shen, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

pandongyan, Principal Investigator, Second Military Medical University

ClinicalTrials.gov Identifier:

NCT04063358

Other Study ID Numbers:

SecondMMU2019

First Posted:

Aug 21, 2019

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2020