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

Diabetic Macular Edema Clinical Trial

Official title:

Comparative Study of the Efficacy of Intravitreal Ranibizumab Versus Its Combination With Commercial Dexamethasone in The Treatment of Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271539
• Other study ID #: MS-278-2020
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 15, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Khaled G Abueleinen	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central foveal thickness	Central foveal thickness in microns measured by OCT	6 months after the first injection
Primary	BCVA (Decimal)	Best corrected visual acuity measured on Snellen chart in Decimal form	6 months after the first injection
Primary	The number of injections	The total number of injections in each Arm group	over 6 months duration of the study
Secondary	IOP	Intraocular pressure	6 months after the first injection