Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Lucentis alone group; Lucentis dexamethasone group
Intervention type(s): Drug; Drug
Intervention description(s): 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 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 MeSH terms: Dexamethasone; Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: None (Open Label)
Primary purpose: Treatment