Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema

NCT00682539 | Completed Phase 4 Results DMC

• 1 other identifier: TRIASTIN Study
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the change in macular edema and the absolute change in visual acuity following intravitreal administered injections of Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) compared with Triamcinolone (Volon A®) in patients with clinical significant diabetic macular edema. The investigators monitor the change in macular edema measured with standard optical coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS).

Conditions

Diabetic Macular Edema

Keywords

diabetic retinopathy; macular edema; intravitreal Avastin/ Triamcinolone / Lucentis

Outcome Measures

Primary Outcomes (2)

• Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.

  Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome

  12 month

• Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)

  Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome

  12 months

Secondary Outcomes (1)

• To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.

  12 month

Study Arms (3)

Avastin

ACTIVE COMPARATOR

15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

Drug: Bevacizumab (Avastin); Drug: Sham

Triamciolone

ACTIVE COMPARATOR

30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns patients will receive a sham injection. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.

Drug: Triamcinolone; Drug: Sham

Lucentis

ACTIVE COMPARATOR

15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if the central retinal thickness measured with optical coherence tomography (Stratus OCT, Zeiss) stays more than 300 microns. If the Central retinal thickness decreases under 300 microns a sham injection is performed.

Procedure: Lucentis

Interventions

Bevacizumab (Avastin) DRUG

The intravitreal injection of Bevacizumab (Avastin®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Also known as: Avastin

Avastin

Triamcinolone DRUG

The intravitreal injection of triamcinolone (Volon A®) is performed in the operating room under sterile conditions at baseline. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.1ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Also known as: Volon A

Triamciolone

Sham DRUG

Patients receiving sham intravitreal injections do not receive an actual injection of study drug. The injecting physician performing the sham injection will be unmasked to the treatment to the treatment assignment regarding active versus sham. The injecting physician will perform the same pre-injection procedures for the patients receiving bevacizumab or triamcinolone, An empty syringe without a needle will be used in the sham injection. The injecting physician will mimic an intraocular injection by making contact with the conjunctiva and applying pressure without the needle. Immediately following the sham injection, the injecting physician will perform the same post-injection procedures as those performed on patients receiving bevacizumab or triamcinolone.

Also known as: sham injection

Avastin; Triamciolone

Lucentis PROCEDURE

The intravitreal injection of Ranibizumab (Lucentis®) is performed in the operating room under sterile conditions. The patient receives an initial drop of lidocaine 4% into the study eye followed by betaisodona solution. Then the lid margins, the lids and the periocular skin are washed carefully with betaisodona. The eye is draped in a sterile fashion. A sterile lid speculum is inserted by the surgeon. Another drop of betaisodona is applied into the eye. A circle is used to mark the injection site 3.5mm from the limbus in the inferior temporal quadrant. The injection is given at the marked site, slowly, at a 90 degree angle. After injecting the total volume of 0.05ml the needle is slowly withdrawn. Another drop of betaisodona is given as well as an antibiotic/steroid ointment.

Lucentis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patients with type 1 or type 2 diabetes mellitus
• Patients with diabetic macular edema with center involvement
• Central macular thickness (macular edema) of at least 300 microns in the central subfield as measured by OCT
• Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/400 (Snellen equivalent) in the study eye
• Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator
• If both eyes are eligible, the one with the worse visual acuity will be selected for study treatment unless, based on medical reason, the investigator deems the other eye have got more benefit from study treatment. The other eye will be treated with Grid laser coagulation.

You may not qualify if:

• A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure
• History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week
• Prior/Concomitant Treatment
• Macular laser photocoagulation
• Panretinal laser photocoagulation within the past 3 months
• Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye
• Previous participation in clinical trial involving anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.)
• History of submacular surgery or other surgical intervention for diabetic macular edema in the study eye Diabetic Retinopathy Characteristics
• High risk proliferative diabetic retinopathy in the study eye without complete panretinal laser photocoagulation and having a risk for intravitreal bleeding Concurrent Ocular Conditions
• Active intraocular inflammation (grade trace or above) in either eye
• Vitreomacular traction in the study eye evident by OCT
• Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularisation
• Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication)
• History of glaucoma filtration surgery, corneal transplantation in the study eye Concurrent Systemic Conditions

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. of Ophthalmology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (2)

• Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

  PMID: 33206392 DERIVED

• Karst SG, Lammer J, Mitsch C, Schober M, Mehta J, Scholda C, Kundi M, Kriechbaum K, Schmidt-Erfurth U. Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):49-58. doi: 10.1007/s00417-017-3828-1. Epub 2017 Oct 28.

  PMID: 29080915 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

Bevacizumab; Triamcinolone; salicylhydroxamic acid; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Katharina Kriechbaum
• Organization: Department of Ophthalmology, Medical University Vienna

katharina.kriechbaum@meduniwien.ac.at

00431 40400 79480

Study Officials

• Ursula Schmidt-Erfurth, MD

  Medical University of Vienna, Dept. of Ophthalmology

  STUDY CHAIR

• Georg Rainer, MD

  Medical University of Vienna, Dept. of Ophthalmology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.Dr.

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)