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Intravitreal Ranibizumab or Triamcinolone
Acetonide in Combination with Laser Photocoagulation for
Diabetic Macular EdemaProtocol Status: Enrollment Completed "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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