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

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ClinicalTrials.gov Identifier: NCT04601675
Recruitment Status : Not yet recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
He Eye Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Edema Drug: Ranibizumab Ophthalmic and Intravitreal Dexamethasone Drug: Ranibizumab Ophthalmic only Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study on Diabetic Macular Edema Patients Receiving Ranibizumab and Dexamethasone or Ranibizumab Only.
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : September 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diabetic ME: Ranibizumab and intravitreal Dexamethasone
Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone
 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
Other Names:
  • Lucentis®
  • Ozurdex®
Active Comparator: Diabetic ME: Ranibizumab
Participants with diabetic macular edema (ME) will receive Ranibizumab only.
 Drug: 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 Name: Lucentis®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Mean change in central subfield retinal thickness [ Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. ]
    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.

  2. Change in Humphrey 10-2 visual field in the treatment eye [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    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.

  3. People meeting driving standards [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and and 6 months.

  4. Mean change in NEI VFQ25 [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Scores from NEI VFQ25 questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.

  5. Mean change in EQ-5D 5L [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Scores from EQ-5D 5L questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.

  6. Mean change in VisQoL scores [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Scores from VisQoL questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.

  7. Mean change in wavefront aberrations [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    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.

  8. Mean change in ocular surface and tear-film [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    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.

  9. Mean change in vessel density [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    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.

  10. Side effects [ Time Frame: 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Side effects are measured by a review of the participant's medical and ophthalmic history.

  11. Use of additional treatments (including laser) [ Time Frame: 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Use of additional treatments (including laser) is assessed by the treating ophthalmologist


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601675


Contacts
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Contact: Jun Li, M.D., Ph.D. 0411-86525401 robin_lijun@sina.com
Contact: Emmanuel E Pazo, M.D., Ph.D. 18612782131 ericpazo@outlook.com

Locations
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China, Liaoning
He Eye Specialist Hospital
Shenyang, Liaoning, China, 110001
Contact: Jun Li, M.D.    15104083505    robin_lijun@sina.com   
Contact: Emmanuel Eric E Pazo    18612782131    ericpazo@outlook.com   
Sub-Investigator: Qiqi Zhong, M.D.         
Sub-Investigator: Lanting Yang, M.D.         
Sponsors and Collaborators
He Eye Hospital
Investigators
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Study Chair: Wei He, M.D., Ph.D. He Eye Specialist Hospital, Shenyang.
Principal Investigator: Jun Li, M.D., Ph.D. He Eye Specialist Hospital, Shenyang.
Study Director: Emmanuel E Pazo, M.D., Ph.D. He Eye Specialist Hospital, Shenyang.
More Information
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Responsible Party: He Eye Hospital
ClinicalTrials.gov Identifier: NCT04601675    
Other Study ID Numbers: ME-230620
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Ranibizumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors