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

NCT04601675 | Unknown DMC

• 1 other identifier: ME-230620
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (11)

• Mean change in central subfield retinal thickness

  Baseline, 1 week, 1month, 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 NEI VFQ25

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

• Mean change in EQ-5D 5L

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

Study Arms (2)

Diabetic ME: Ranibizumab and intravitreal Dexamethasone

EXPERIMENTAL

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

Drug: Ranibizumab Ophthalmic and Intravitreal Dexamethasone

Diabetic ME: Ranibizumab

ACTIVE COMPARATOR

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

Drug: Ranibizumab Ophthalmic only

Interventions

Ranibizumab Ophthalmic and Intravitreal Dexamethasone DRUG

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

Also known as: Lucentis®, Ozurdex®

Diabetic ME: Ranibizumab and intravitreal Dexamethasone

Ranibizumab Ophthalmic only DRUG

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

Also known as: Lucentis®

Diabetic ME: Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Specialist Hospital

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Wei He, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  STUDY CHAIR

• Jun Li, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  PRINCIPAL INVESTIGATOR

• Emmanuel E Pazo, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  STUDY DIRECTOR

Central Study Contacts

Jun Li, M.D., Ph.D.

CONTACT

0411-86525401; robin_lijun@sina.com

Emmanuel E Pazo, M.D., Ph.D.

CONTACT

18612782131; ericpazo@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: October 31, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 17, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)