Bevacizumabe or Triamcinolone for Persistent Diabetic Macular Edema

NCT02985619 | Completed Phase 2 DMC

• 1 other identifier: 1.599.864
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• OCT measurements

  Optical Coherence Tomography measurements in the central subfield thickness between baseline and 6 months 1st endpoint.

  6 months.

Study Arms (3)

IVB randomised group I

ACTIVE COMPARATOR

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.

Drug: Bevacizumab Injection [Avastin] (IVB-I)

IVT randomised group II

ACTIVE COMPARATOR

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.

Drug: Triamcinolone Acetonide 10mg/mL (IVT-II)

IVB group III (not randomised)

ACTIVE COMPARATOR

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.

Drug: Bevacizumab Injection [Avastin] (IVB-III)

Interventions

Bevacizumab Injection [Avastin] (IVB-I) DRUG

0,05ml intravitreal injection

Also known as: Avastin®

IVB randomised group I

Triamcinolone Acetonide 10mg/mL (IVT-II) DRUG

0,03ml intravitreal injection

Also known as: OPTHTAAC®

IVT randomised group II

Bevacizumab Injection [Avastin] (IVB-III) DRUG

0,05ml intravitreal injection

Also known as: Avastin®

IVB group III (not randomised)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic macular edema with \>300µm on central subfield macular thickness by OCT;
• Best corrected vision acuity minimum: 20/32 to 20/320;

You may not qualify if:

• Vitreomacular traction;
• Macular ischemia;
• Laser or injection therapy before 3 months to assign the protocol.\\
• Pregnancy;

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Interventions

Bevacizumab; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: USP Ribeirao Preto

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 7, 2016
• Study Start: July 21, 2016
• Primary Completion: April 14, 2017
• Study Completion: December 21, 2017
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share