Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.
Overview
- Phase
- Not Applicable
- Intervention
- Ranibizumab Ophthalmic and Intravitreal Dexamethasone
- Conditions
- Macular Edema
- Sponsor
- He Eye Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mean change in binocular BCVA
- Last Updated
- 5 years ago
Overview
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.
Investigators
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:
- •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
Arms & Interventions
Diabetic ME: Ranibizumab and intravitreal Dexamethasone
Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone
Intervention: Ranibizumab Ophthalmic and Intravitreal Dexamethasone
Diabetic ME: Ranibizumab
Participants with diabetic macular edema (ME) will receive Ranibizumab only.
Intervention: Ranibizumab Ophthalmic only
Outcomes
Primary Outcomes
Mean change in binocular BCVA
Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Mean change in monocular BCVA in the treatment eye
Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Secondary Outcomes
- Mean change in EQ-5D 5L(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in VisQoL scores(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in wavefront aberrations(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Change in Humphrey 10-2 visual field in the treatment eye(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- People meeting driving standards(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in central subfield retinal thickness(Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.)
- Mean change in NEI VFQ25(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in ocular surface and tear-film(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Mean change in vessel density(Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.)
- Side effects(1 week, 1 month, 2 months, 3 months, and 6 months.)
- Use of additional treatments (including laser)(1 week, 1 month, 2 months, 3 months, and 6 months.)