Clinical trial NCT04601675: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in monocular BCVA in the treatment eye
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in binocular BCVA
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary outcomes:
measure: Mean change in central subfield retinal thickness
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Change in Humphrey 10-2 visual field in the treatment eye
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: People meeting driving standards
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in NEI VFQ25
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in EQ-5D 5L
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in VisQoL scores
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in wavefront aberrations
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in ocular surface and tear-film
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in vessel density
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Side effects
timeFrame: 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Use of additional treatments (including laser)
timeFrame: 1 week, 1 month, 2 months, 3 months, and 6 months.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Specialist Hospital
state: Liaoning
Study officials:
affiliation: He Eye Specialist Hospital, Shenyang.
name: Wei He, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Jun Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Emmanuel E Pazo, M.D., Ph.D.
role: STUDY_DIRECTOR
References: