Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Status: Closed
Start Date: 06/14/2010
End Date: 12/21/2012
Clinical Trial ID: NCT00996437
Public Dataset:  Download

A. Study Design

·          Prospective, multi-center randomized clinical trial

 

B. Major Eligibility Criteria

·          Age >=18 years

·          Type 1 or type 2 diabetes

·          Study eye with

o   Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, and precluding completion of panretinal photocoagulation (or precluding assessment of completeness of prior PRP)

o   Immediate vitrectomy not required

o   Visual acuity is light perception or better

 

C. Intervention and Follow-up Visits

Eyes will be randomly assigned to one of two treatment groups:

·         Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks

·         Saline injection at baseline, 4 and 8 weeks

Follow-up study injections at 4 and 8 weeks are not performed if the hemorrhage has sufficiently cleared such that complete PRP can be given (or it is determined that complete PRP was already given) or if a vitrectomy has already been performed. The subject and all study personnel will be masked to the treatment group assignment through the end of the study.

 

D. Sample Size

  • Approximately 260 study eyes, one per subject, will be randomized in this study.

E. Follow-up Schedule

Follow-up visits occur for all subjects at 4, 8, 12, and 52 weeks.  A phone call is performed at 26 weeks to maintain contact with the subject.  Data regarding the completion of vitrectomy is collected at the time of the vitrectomy. 

 

F. Main Efficacy Outcomes

 “Failure” defined as vitrectomy completed within 112 days of randomization (inclusive of 112).  

 

G. Main Safety Outcomes

Injected-related: endophthalmitis, retinal detachment

Ocular drug-related: traction retinal detachment, inflammation, cataract/cataract surgery, IOP/glaucoma, iritis, iris/angle neovascularization, neovascular glaucoma

Systemic drug-related: cardiovascular events

 

 H. Schedule of Study Visits and Examination Procedures

 

0

4w

8w

12w

26w

(phone

Call)

52w

Visit Window

 -

±1w

±1w

±1w

±2w

±2w

E-ETDRS best corrected visual acuity a

X

X

X

X

 

X

Medical update b

 

X

X

X

X

X

OCT c

X

X

X

 

X

Ultrasound d

X

X

X

X

 

X

Eye Exam e  

X

X

X

X

 

X

Blood pressure

X

 

 

 

 

 

HbA1c f  

X

 

 

 

 

 

Ranibizumab or saline injection (masked)

X

 X g

 X g

 

 

 

 Notes:

 

a=both eyes including protocol refraction in the study eye at baseline, 12-week and 52-week visits. Visual acuity at baseline is performed with or without pupil dilation.  E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.

b= including determining whether vitrectomy has been performed (except at 26 week phone call)

c=study eye only

d= study eye only as part of standard care if the density of the vitreous hemorrhage precludes assessment of retinal detachment.

e=both eyes at baseline and at follow-up visits. Includes slit lamp exam (including assessment of lens), measurement of intraocular pressure, and dilated ophthalmoscopy

f=can be obtained up to 3 weeks after randomization; does not need to be repeated if HbA1c is available from within the prior 3 months

g= only performed if eye has not already received vitrectomy or complete PRP

 



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