Trial record 19 of 259 for:    Open Studies | "Edema"

Intraocular Bevacizumab Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema (TRIASTIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Katharina Kriechbaum, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00682539
First received: May 20, 2008
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Diabetic Macular Edema
Drug: Bevacizumab (Avastin)
Drug: Triamcinolone
Drug: Sham
Procedure: Lucentis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked Study With Intraocular Anti-VEGF (Avastin®/Lucentis®) Compared With Intraocular Triamcinolone (Volon A®) in Patients With Clinical Significant Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Efficacy of the treatment assessed with visual acuity measured by ETDRS charts and central retinal thickness as measured by standard Optical Coherence Tomography (OCT) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Avastin
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)
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.
Other Name: Avastin
Drug: Sham
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.
Active Comparator: Triamciolone
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
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.
Other Name: Volon A
Drug: Sham
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.
Active Comparator: Lucentis
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patients without a necessity for panretinal laser photocoagulation for at least 3 months after study inclusion
  • 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.

Exclusion Criteria:

  • 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
  • History of myocardial infarction (in anamnesis or signs in ECG)
  • History of congestive heart failure
  • History of stroke or transient ischemic attacks
  • Significant abnormalities on laboratory testing (signs on failure of kidney, liver disease)
  • Premenopausal women not using adequate contraception and pregnant or nursing women
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
  • Current treatment for active systemic infection Other
  • History of allergy to fluorescein, not amenable to treatment
  • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded
  • Inability to comply with study or follow up procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682539

Contacts
Contact: Georg Rainer, MD 43-40-400 ext 7941 georg.rainer@meduniwien.ac.at
Contact: Katharina Kriechbaum, MD 43-40-400 ext 7941 katharina.kriechbaum@meduniwien.ac.at

Locations
Austria
Dept. of Ophthalmology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Georg Rainer, MD    43-40-400 ext 7941    georg.rainer@meduniwien.ac.at   
Contact: Katharina Kriechbaum, MD    43-40-400 ext 7941    katharina.kriechbaum@meduniwien.ac.at   
Sub-Investigator: Sonja G. Prager, MD         
Principal Investigator: Katharina Kriechbaum, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Ursula Schmidt-Erfurth, MD Medical University of Vienna, Dept. of Ophthalmology
Principal Investigator: Georg Rainer, MD Medical University of Vienna, Dept. of Ophthalmology
  More Information

No publications provided

Responsible Party: Katharina Kriechbaum, Ass.Prof.Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00682539     History of Changes
Other Study ID Numbers: TRIASTIN Study
Study First Received: May 20, 2008
Last Updated: May 31, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
diabetic retinopathy
macular edema
intravitreal Avastin/ Triamcinolone / Lucentis

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014