Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

 

Protocol Status: Currently Enrolling Patients

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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
    • severe nonproliferative or proliferative diabetic retinopathy for which the investigator intends to perform full scatter photocoagulation
    • diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 microns) and reducing visual acuity to 20/32 or worse

 

C. Intervention and Follow-up Visits

Approximately 381 study eyes (one per subject) will be randomly assigned with equal probability to one of the following three injection groups:

  • Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and 4 weeks
  • Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
  • Sham injection at baseline and 4 weeks

 

The initial injection (or sham) is given on the day of randomization. 

 

Focal (macular) photocoagulation is given 7 to 10 days following the injection. 

 

Panretinal (scatter) photocoagulation can be initiated either on the same day as the focal photocoagulation (immediately following the focal photocoagulation) or on a subsequent day but must be initiated within 14 days of the baseline injection.

  • Panretinal photocoagulation will consist of 1200 to 1600 burns given over 1 to 3 sittings, with completion of the regimen within 49 days of randomization.
  • To avoid bias, the investigator will need to declare prior to randomization the number of sittings planned to complete the PRP relative to the initial injection (or sham), and the approximate number of burns planned for each sitting.

 

Required follow-up visits occur at 4 weeks and 14 weeks (primary outcome).

  • A second injection (or sham) is given at the 4-week visit (intravitreal injection for the ranibizumab group and a sham injection for the other two groups).
  • After the 14-week visit, additional treatment can be given at investigator discretion during the safety phase of the study.

                       

Additional safety visits will be performed at 34 weeks after randomization and at 56 weeks (which is 52 weeks after the last study injection).

 

D. Main Efficacy Outcomes

Primary: visual acuity at 14 weeks adjusted for the baseline acuity.

 

Secondary Outcomes at 14 Weeks

  • Change in retinal thickening from baseline (OCT central subfield and retinal volume)
  • Presence and extent of new vessels on fundus photographs
  • Vitreous hemorrhage
  • Additional sessions of scatter photocoagulation due to worsening PDR before 14 week visit after completion of initial session

 

E. Main Safety Outcomes

Injected-related: endophthalmitis, retinal detachment

Ocular drug-related: inflammation, cataract/cataract surgery, IOP/glaucoma

Systemic drug-related: cardiovascular events

 

F. Schedule of Study Visits and Procedures

 

Study Visits

 

Study Time

 

0

Randomization

1st injection*

7-10 days

Safety visit

Focal (macular) photocoagulation

7-14 days

Initial sitting of panretinal photocoagulation (following focal photocoagulation)

28 (24-32) days

 

Follow-up exam

2nd injection*

49 days

Last day to complete panretinal photocoagulation

98 (91-105) days

Primary outcome exam

34 (32-36) weeks

Safety follow-up visit

56 (54-58) weeks

Safety follow-up visit

 

              *Phone call to subject performed 4+2 days after each injection

 

Examination Procedures

 

 

0

1w

4w

14w

34w

56w

Visit window

-

7 to 10 d

+ 4d

+1w

+2w

+2w

E-ETDRS best corrected visual acuitya

X

X

X

X

X

X

Fundus photosb

X

 

 

X

 

X

OCTc

X

X

X

X

X

X

Eye examd

X

X

X

X

X

X

Blood pressure

X

 

 

 

 

 

HbA1ce

X

 

 

 

 

 

 

Notes:

a = both eyes at each visit; includes protocol refraction in study eye at each visit except 1-week visit when baseline refraction is used. Protocol refraction in nonstudy eye is only required at baseline, 14 weeks, and 56 weeks.  E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.

b = both eyes at baseline, study eye only at 14 wks and 56 wks

c = study eye only

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

e = 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

 

 

 

 

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