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Intravitreal
Ranibizumab or Triamcinolone Acetonide in Combination with Laser
Photocoagulation for
Diabetic Macular EdemaProtocol
Status: Currently Enrolling Patients "Click
here to view protocol slide set" A. Study Design ·
Randomized, multi-center clinical trial B. Major Eligibility Criteria ·
Age >=18 years. ·
Type 1 or type 2 diabetes ·
Diabetic macular edema involving the center of the macula (OCT central
subfield thickness >250 microns) responsible for visual acuity of 20/32 or
worse C. Treatment Groups Randomization
to one of the following 4 groups: 1)
Group A: Sham injection
plus focal (macular) photocoagulation 2)
Group B: 0.5 mg injection
of intravitreal ranibizumab plus focal photocoagulation 3)
Group C: 0.5 mg injection
of intravitreal ranibizumab plus deferred focal laser photocoagulation 4)
Group D: 4 mg intravitreal
triamcinolone plus focal photocoagulation In groups A, B and
D, laser will be given 7-10 days after the initial injection at the time of
the injection follow-up safety visit. Subjects may have
one or two study eyes. Subjects with
two study eyes will receive sham injection/focal photocoagulation in one eye
and the other eye will be assigned to one of the three other groups. During the first year, subjects are evaluated for
retreatment every 4 weeks based on OCT and visual acuity criteria. D. Sample Size
E.
Duration of Follow-up
F. Follow-up Schedule
G. Main Efficacy Outcomes Primary: Visual acuity at 12 months adjusted for the
baseline acuity Secondary: Change in retinal thickening of central subfield
and retinal volume measured on OCT Number of injections in first year H. Main Safety Outcomes Injected-related: endophthalmitis,
retinal detachment Ocular drug-related: inflammation,
cataract, cataract surgery, increased intraocular pressure, glaucoma
medications, glaucoma surgery Systemic
drug-related: cardiovascular events I. Schedule of Study Visits and Examination
Procedures First Year
Notes: 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. a = both
eyes at each visit; includes protocol refraction in study eye at each visit
except 1 wk visit when baseline refraction is used. Protocol refraction in
nonstudy eye is only required at baseline and annual visits. E-ETDRS refers to electronic ETDRS testing
using the Electronic Visual Acuity Tester that has been validated against
4-meter chart ETDRS testing. b = study eye only c = both
eyes at baseline and follow-up visits.
Includes slit lamp exam (including assessment of lens), measurement of
intraocular pressure, and dilated ophthalmoscopy. d = 7-fields;
both eyes at baseline and study eye only at 52 weeks. e = does not need to be repeated if HbA1c is
available from within the prior 3 months.
If not available, can be performed within 3 weeks after randomization. Second and
Third Years Visits continue at
4-week intervals as long as intravitreal injections are being given;
otherwise visits are every 4 months.
Regardless of the interval, the examination procedures are the same as
listed above for 4-week visits, with 7-field photographs of the study eye
obtained at the 3-year visit only. |
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