Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
Status: Closed
Start Date: 05/01/2005
End Date: 02/29/2008
Clinical Trial ID: NCT00336323
Public Dataset:  Download

 

A Phase 2 Evaluation of Anti-VEGF Therapy for

Diabetic Macular Edema: Bevacizumab (Avastin)

Protocol Status: Completed

"Click here to view protocol"

A. Study Design

  • Phase 2 randomized, multi-center clinical trial

B. Objectives

  • To assess the dose and dose interval related effects of intravitreal administered bevacizumab on central retinal thickness and visual acuity in subjects with diabetic macular edema (DME).
  • To assess the effect on intravitreal bevacizumab combined with macular photocoagulation in DME.
  • To assess the safety of intravitreal bevacizumab in subjects with DME.

This phase 2 study is being conducted (1) to determine whether the conduct of a phase 3 trial has merit and (2) to provide information needed to design a phase 3 trial. The study is not designed to establish the efficacy of bevacizumab in the treatment of diabetic macular edema.

C. Major Eligibility Criteria

  • Age >=18 years.
  • Study eye with best corrected E-ETDRS acuity >= 24 letter score (20/320 or better) and <= 78 letter score (20/32 or worse).
  • Fellow eye has acuity >= 19 letters (20/400 or better) and has not had anti-VEGF treatment within the past 3 months and there is no expectation of such treatment in the next 3 months.

D. Treatment
The study eye will be randomly assigned to one of the following 5 groups stratified by visual acuity:

1.  Laser photocoagulation at baseline

o        If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart

2.  1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks

3.  2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks

4.  1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)

1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks. 

E. Duration of Follow-Up: 70 weeks

F. Outcomes:

  • Central subfield thickening measured on OCT
  • Visual acuity (measured with E-ETDRS)

G. Safety Outcomes:

1.  Visual acuity decrease of 20 or more letters at any visit within the first 3 weeks after a bevacizumab injection.

2.  Ocular inflammation

3.  Endophthalmitis at any time (defined as any patient treated for infectious endophthalmitis regardless of whether a culture is positive).

4.  Other reported adverse events: injection-related, ocular, systemic.

H. Schedule of Study Visits and Examination Procedures

 

Study Week

 

0*

3

6*

9

12

18

24

41

70

E-ETDRS visual acuity b

Xa

X

X

X

X

X

X

X

X

OCT c

Xa

 X

X

X

X

Xd

Xd

Fundus photos (7F)

X

 

 

 

 

 

 

 

 

Eye Exam

X

X

X

X

X

X

X

X

X

Blood Pressure

X

X

X

X

X

X

X

X

X

HbA1c

X

 

 

 

 

 

 

 

 

Notes:

1. A medical history will be elicited at baseline and an updated history at each visit. Concomitant medications will be recorded at baseline and updated at each visit. Adverse events will be recorded at each visit.

2. Testing is on both eyes at each visit, except for OCT and photos which are only performed on the study eye.

* injection of study drug at baseline and 6 weeks.

a =

If completed more than 8 days prior to randomization, must be repeated on day of randomization.

b =

measurement of best-corrected visual acuity includes protocol refraction at baseline and at 9 weeks, and at other visits if there is a 10 or more letter decrease from baseline; otherwise, refraction from most recent visit is used. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.

c =

OCT3, software version 4 (or later).

d =

only if performed as part of usual care.

 
 

 



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