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Combined Triple Therapy in Diabetic Retinopathy (DRP)

Primary Purpose

Macular Edema, Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
triamcinolone and bevacizumab
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of diabetic retinopathy

    • macular edema more than 200 micron
    • vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

Exclusion Criteria:

  • Prior intraocular injection within 4 months
  • Core or complete vitrectomy
  • History of glaucoma or ocular hypertension
  • Presence of iris neovascularization
  • Significant media opacity
  • Monocularity and pregnancy

Sites / Locations

  • Department of Vitreoretinal Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

group I (n=17) nonproliferative DR and ischemic maculopathy

group II (n=38) nonproliferative DR without ischemic maculopathy

group III (n=18) proliferative DR with or without ischemic maculopathy

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity

Secondary Outcome Measures

Full Information

First Posted
December 4, 2008
Last Updated
September 26, 2012
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00806169
Brief Title
Combined Triple Therapy in Diabetic Retinopathy (DRP)
Official Title
Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.
Detailed Description
This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic Retinopathy
Keywords
combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
group I (n=17) nonproliferative DR and ischemic maculopathy
Arm Title
2
Arm Type
Experimental
Arm Description
group II (n=38) nonproliferative DR without ischemic maculopathy
Arm Title
3
Arm Type
Experimental
Arm Description
group III (n=18) proliferative DR with or without ischemic maculopathy
Intervention Type
Drug
Intervention Name(s)
triamcinolone and bevacizumab
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
Day of exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of diabetic retinopathy macular edema more than 200 micron vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS Exclusion Criteria: Prior intraocular injection within 4 months Core or complete vitrectomy History of glaucoma or ocular hypertension Presence of iris neovascularization Significant media opacity Monocularity and pregnancy
Facility Information:
Facility Name
Department of Vitreoretinal Surgery
City
Frankfurt / Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

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Combined Triple Therapy in Diabetic Retinopathy (DRP)

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