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

Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063358
• Other study ID #: SecondMMU2019
• Status: Recruiting
• Phase: Phase 3
• Start date: August 22, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2020
• Source: Second Military Medical University
• Contact: dongyan pan
• Phone: 86-21-31161995
• Email: campus[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Lucentis
Lucentis 0.5 MG Per 0.05 ML Injection

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total number of postoperative injections	Total number of postoperative injections will be calculated	12 months after cataract surgery
Secondary	percentage of patients with diabetic retinopathy progression	patients with diabetic retinopathy progression will be calculated	12 months after cataract surgery