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

NCT ID: NCT05271539

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-09-15

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.

Detailed Description

This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.

Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.

Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.

Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.

. The number of injections needed to achieve the same effect on CMT and BCVA.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The first group, Lucentis alone group

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.

Group Type: ACTIVE_COMPARATOR

Lucentis alone group

Intervention Type: 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 second group, Lucentis dexamethasone group

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).

Group Type: ACTIVE_COMPARATOR

Lucentis dexamethasone group

Intervention Type: 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.

Interventions

Lucentis alone group

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

Intervention Type: DRUG

Lucentis dexamethasone group

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• ● 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

khaled gamal abueleinen

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled G Abueleinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology department, Faculty of Medicine Cairo University

Locations

Khaled G Abueleinen

Giza, Cairo Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29127949 (View on PubMed)

Other Identifiers

MS-278-2020

Identifier Type: -

Identifier Source: org_study_id