Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema

NCT05271539 | Completed Phase 3 DMC

• 1 other identifier: MS-278-2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (3)

• Central foveal thickness

  Central foveal thickness in microns measured by OCT

  6 months after the first injection

• BCVA (Decimal)

  Best corrected visual acuity measured on Snellen chart in Decimal form

  6 months after the first injection

• The number of injections

  The total number of injections in each Arm group

  over 6 months duration of the study

Secondary Outcomes (1)

• IOP

  6 months after the first injection

Study Arms (2)

The first group, Lucentis alone group

ACTIVE COMPARATOR

The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle.

Drug: Lucentis alone group

The second group, Lucentis dexamethasone group

ACTIVE COMPARATOR

The second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).

Drug: Lucentis dexamethasone group

Interventions

Lucentis alone group DRUG

The Lucentis alone group received 3 monthly intravitreal injections of lucentis alone or less than 3 injections if the central foveal thickness reached 250 microns

The first group, Lucentis alone group

Lucentis dexamethasone group DRUG

Lucentis dexamethasone group received intravitreal injections of combination of both lucentis and commercial dexamethasone. the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN). Treatment was stopped when CMT improved below 250 µ.

The second group, Lucentis dexamethasone group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography \[OCT\]).
• Best corrected visual acuity of 6/12 or less.

You may not qualify if:

• ● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months
• History of panretinal photocoagulation within the last 6 months.
• PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
• Macular ischemia, as indicated with Fluorescein Angiography.
• Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
• Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
• Vitreomacular traction syndrome.
• Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
• Glaucoma, whether suspected or confirmed.
• Significant media opacity.
• Patients with ocular or periocular infections, or infection in the other eye
• Signs of Active or resolved uveitis and intraocular inflammation.
• Bad diabetic control as indicated by HbA1C \>8.
• Renal impairment, hepatic impairment, or congestive heart failure.
• History of cardiovascular insult or stroke.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Khaled G Abueleinen

Giza, Cairo Governorate, 12411, Egypt

Location

Related Publications (1)

• Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914.

  PMID: 29127949 BACKGROUND

Study Officials

• Khaled G Abueleinen, MD, PhD

  Ophthalmology department, Faculty of Medicine Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: The first group received 3 monthly intravitreal injections of 0.5 mg in 0.05 mL ranibizumab alone (Lucentis, by Novartis), aspirated from vial through 5-micron sterile filter needle (19-gauge × 1-1/2 inch), with a 1-mL syringe and injected through a 30-gauge × ½ inch sterile injection needle. While the second group received monthly intravitreal injections of the same dose of ranibizumab combined with 0.4 mg in 0.1 ml dexamethasone (Dexamethasone sodium phosphate, Amriya Pharmaceuticals, Cairo, Egypt) in a separate 1ml syringe with 27- gauge × ½ inch sterile injection needle, followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline i.e., PRN).

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 15, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

EG (1)