Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema

Sponsor
University of Sao Paulo
Study ID
NCT02985619
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

Background: Diabetic macular edema (DME) shows a sustained functional and morphologic response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal approach for persistent macular edema still in debate. Purpose: To evaluate 24-week visual and anatomical effects of intravitreal bevacizumabe or triamcinolone in patients who have residual edema after 24-weeks to "pro re nata"(prn) intravitreal bevacizumabe therapy. Methods: This study will enroll a total of 100 DME eyes. Each patient will receive "prn" bevacizumabe therapy throughout 24 weeks. At week 24, patients who have recurrent or persistent edema were randomized 1:1 to Group 1 (prn bevacizumane) or Group 2 (prn triamcinolone). Patients with no recurrent or persistent edema at week 24 will comprise to Group 3 and continue receive prn bevacizumabe. Prn treatment was administered when central subfield thickness of the macula (CST) \> 300 µm and/or there are intraretinal cystoid spaces in the fovea. Study visits will occur every 4 weeks with the endpoint at week 48. At each visit, patients will have an eye exam and CST, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were assessed. Fundus photography and fluorescein angiography will also perform at baseline, week 16, week 40, and week 48. All patients will resume standard care after exiting.

Key Dates

First listed
Dec 7, 2016
Start date
Jul 21, 2016
Status verified
May 2022
Primary completion
Apr 14, 2017
Completion
Dec 21, 2017

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: IVB randomised group I
    Randomised patients \[intravitreal bevacizumab (IVB) group I\] with central foveal thickness \>300µm on OCT will be submitted to 6 months treatment with 0.05ml (1.25mg) intravitreous injection of Bevacizumabe "prn" (pro re nata, or as needed), with monthly visits for central subfoveal thickness map more than 300µm by Optic Coherence Tomography. Care will be take in all cases to insure that the needle do not touch the lids or lashes. Bevacizumab (1.25 mg/0.05 cc; F. Hoffmann- La Roche Ltd., Basel, Switzerland) will be inject into the vitreous cavity using a 29-gauge 0.5- inch needle insert through the superotemporal pars plana 3.0-3.5 mm posterior to the limbus.
  • Active Comparator: IVT randomised group II
    Randomised patients \[intravitreal triamcinolone (IVT) group II\] with central foveal thickness \>300µm on OCT will be submitted to 6 months treatment with 0.03ml (1.20mg) intravitreous injection of triamcinolone each 3 months (prn, as needed) for central sufoveal thickness map more than 300µm by Optic Coherence Tomography. Care will be take in all cases to insure that the needle do not touch the lids or lashes. Triamcinolone (1.20 mg/ 0.03 cc; Opthaac, Ophthalmos, São Paulo, Brazil) will be inject into the vitreous cavity using a 29-gauge 0.5- inch needle insert through the superotemporal pars plana 3.0-3.5 mm posterior to the limbus.
  • Active Comparator: IVB group III (not randomised)
    Patients with central foveal thickness ≤300µm at week visit 24 will be allocated to group III (IVB, intravitreal bevacizumab). So, it won't get IVB injection at week visit 24 due OCT regular thickness (≤300µm) but will do regular monthly follow-up visits and prn-IVB therapy if central foveal thickness \>300µm on OCT until last visit of study (48 week-visit). Care will be take in all cases to insure that the needle do not touch the lids or lashes. Bevacizumab (1.25 mg/0.05 cc; F. Hoffmann- La Roche Ltd., Basel, Switzerland) will be inject into the vitreous cavity using a 29-gauge 0.5- inch needle insert through the superotemporal pars plana 3.0-3.5 mm posterior to the limbus.

Primary Outcome Measure

OCT measurements [ Time Frame: 6 months. ]

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