Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.
NCT ID: NCT04601675
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-10-31
2021-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diabetic ME: Ranibizumab and intravitreal Dexamethasone
Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone
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
Diabetic ME: Ranibizumab
Participants with diabetic macular edema (ME) will receive Ranibizumab only.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei He, M.D., Ph.D.
Role: STUDY_CHAIR
He Eye Specialist Hospital, Shenyang.
Jun Li, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo, M.D., Ph.D.
Role: STUDY_DIRECTOR
He Eye Specialist Hospital, Shenyang.
Locations
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He Eye Specialist Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ME-230620
Identifier Type: -
Identifier Source: org_study_id