Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.

Macular Edema Clinical Trial

Official title:

Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04601675
• Other study ID #: ME-230620
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: September 17, 2021

Study information

• Verified date: June 2020
• Source: He Eye Hospital
• Contact: Jun Li, M.D., Ph.D.
• Phone: 0411-86525401
• Email: robin_lijun[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.

Description:

The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 17, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:

1. Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR

2. Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND

3. Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)

4. Amenable to laser treatment, as judged by the treating ophthalmologist

5. Over 18 years of age

Exclusion Criteria:

Eyes of patients will not be included in the study if:

1. The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others

2. The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist

3. The eye has DMO and central subfield retinal thickness (CST) of > 400 microns.

4. The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.

5. The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.

6. The eye has received macular laser treatment within the previous 12 months.

7. The eye has received intravitreal injection of steroids.

8. The eye has received cataract surgery within the previous six weeks

9. The eye has received panretinal photocoagulation within the previous 3 months

10. Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study

11. The patient has chronic renal failure requiring dialysis or kidney transplant

12. The patient has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)

13. The patient has very poor glycemic control and started intensive therapy within the previous 3 months

14. The patient will use an investigational drug during the study

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab Ophthalmic and Intravitreal Dexamethasone
Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema
• Ranibizumab Ophthalmic only
Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.

Locations

Country	Name	City	State
China	He Eye Specialist Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in monocular BCVA in the treatment eye	Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Primary	Mean change in binocular BCVA	Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in central subfield retinal thickness	Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT), from baseline to 6 months.	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Change in Humphrey 10-2 visual field in the treatment eye	Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	People meeting driving standards	Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in NEI VFQ25	Scores from NEI VFQ25 questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in EQ-5D 5L	Scores from EQ-5D 5L questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in VisQoL scores	Scores from VisQoL questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in wavefront aberrations	Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in ocular surface and tear-film	Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Mean change in vessel density	Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Side effects	Side effects are measured by a review of the participant's medical and ophthalmic history.	1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary	Use of additional treatments (including laser)	Use of additional treatments (including laser) is assessed by the treating ophthalmologist	1 week, 1 month, 2 months, 3 months, and 6 months.