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

Primary Purpose

Macular Edema

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ranibizumab Ophthalmic and Intravitreal Dexamethasone

Ranibizumab Ophthalmic only

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

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

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:

Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR
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
Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
Amenable to laser treatment, as judged by the treating ophthalmologist
Over 18 years of age

Exclusion Criteria:

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

The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
The eye has DMO and central subfield retinal thickness (CST) of > 400 microns.
The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
The eye has received macular laser treatment within the previous 12 months.
The eye has received intravitreal injection of steroids.
The eye has received cataract surgery within the previous six weeks
The eye has received panretinal photocoagulation within the previous 3 months
Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
The patient has chronic renal failure requiring dialysis or kidney transplant
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)
The patient has very poor glycemic control and started intensive therapy within the previous 3 months
The patient will use an investigational drug during the study

Sites / Locations

He Eye Specialist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diabetic ME: Ranibizumab and intravitreal Dexamethasone

Diabetic ME: Ranibizumab

Arm Description

Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone

Participants with diabetic macular edema (ME) will receive Ranibizumab only.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

Side effects

Side effects are measured by a review of the participant's medical and ophthalmic history.

Use of additional treatments (including laser)

Use of additional treatments (including laser) is assessed by the treating ophthalmologist

Full Information

NCT ID

NCT04601675

First Posted

October 20, 2020

Last Updated

October 20, 2020

Sponsor

He Eye Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04601675

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 31, 2020 (Anticipated)

Primary Completion Date

March 1, 2021 (Anticipated)

Study Completion Date

September 17, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

He Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diabetic ME: Ranibizumab and intravitreal Dexamethasone

Arm Type

Experimental

Arm Description

Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone

Arm Title

Diabetic ME: Ranibizumab

Arm Type

Active Comparator

Arm Description

Participants with diabetic macular edema (ME) will receive Ranibizumab only.

Intervention Type

Drug

Intervention Name(s)

Ranibizumab Ophthalmic and Intravitreal Dexamethasone

Other Intervention Name(s)

Lucentis®, Ozurdex®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ranibizumab Ophthalmic only

Other Intervention Name(s)

Lucentis®

Intervention Description

Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.

Primary Outcome Measure Information:

Title

Mean change in monocular BCVA in the treatment eye

Description

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.

Time Frame

Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.

Title

Mean change in binocular BCVA

Description

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.

Time Frame

Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.

Secondary Outcome Measure Information:

Title

Mean change in central subfield retinal thickness

Description

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.

Time Frame

Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.

Title

Change in Humphrey 10-2 visual field in the treatment eye

Description

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.

Time Frame