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A Randomized, Double-masked Study With Intraocular Bevacizumab Compared With Intravitreal Ranibizumab in Patients With Persistent Diabetic Macular Edema or Persistent Active Neovascularisation Following Lasercoagulation


Phase 3
18 Years
N/A
Not Enrolling
Both
Diabetic Retinopathy, Diabetic Macula Edema, Proliferative Diabetic Retinopathy

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Trial Information

A Randomized, Double-masked Study With Intraocular Bevacizumab Compared With Intravitreal Ranibizumab in Patients With Persistent Diabetic Macular Edema or Persistent Active Neovascularisation Following Lasercoagulation


Inclusion Criteria:



- Age ≥18 years

- Patients with type 1 or type 2 diabetes mellitus

- HbA1C between 6% and 9 %.

- Patients with persistent diabetic macular edema with center involvement following
completed grid lasercoagulation in the study eye

- Patients with persistent active neovascularisations following completed panretinal
lasercoagulation (at least 2000 spots) in the study eye

- Last perifoveolar laser treatment 3 months before study entry

- Central macular thickness (macular edema) of at least 300 - 550 microns in the
central subfield as measured by OCT

- Not eligible for any currently approved treatments or experimental protocols

- Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/200 (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

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

- Panretinal laser photocoagulation within the past 3 months or macular laser
photocoagulation within the past 3 months in the study eye

- 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 (pegabtanib
sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.)

- History of submacular surgery or other surgical intervention for diabetic macular
edema except grid lasercoagulation in the study eye

- Previous participation in any studies of investigational drugs within 1 month
preceding Day 0 (excluding vitamins and minerals)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To investigate the change in macular edema and the absolute change in visual acuity. To investigate the change of neovascularisation.

Outcome Time Frame:

12 Months

Safety Issue:

Yes

Principal Investigator

Ursula Schmidt-Erfurth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dep. of Ophthalmology, Medical University of Vienna

Authority:

Austria: Ethikkommission

Study ID:

238/2006

NCT ID:

NCT00545870

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Diabetic Retinopathy
  • Diabetic Macula Edema
  • Proliferative Diabetic Retinopathy
  • Diabetic Retinopathy
  • Edema
  • Retinal Diseases

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