Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy (LRTforDME+PRP)
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ClinicalTrials.gov Identifier: NCT00445003 |
Recruitment Status :
Completed
First Posted : March 8, 2007
Results First Posted : July 13, 2011
Last Update Posted : August 26, 2016
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Condition or disease | Intervention/treatment | Phase |
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Proliferative Diabetic Retinopathy Diabetic Macular Edema | Drug: Ranibizumab Drug: Triamcinolone Acetonide Behavioral: Sham injection Procedure: Focal/grid laser | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 333 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
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Experimental: Sham injection plus laser
Sham injection at baseline and 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
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Behavioral: Sham injection
Sham injection at baseline and 4 weeks Procedure: Focal/grid laser Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups. |
Experimental: 0.5mg Ranibizumab plus laser
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
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Drug: Ranibizumab
Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks
Other Name: Lucentis™ Procedure: Focal/grid laser Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups. |
Active Comparator: 4-mg Triamcinolone Acetonide plus Laser
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
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Drug: Triamcinolone Acetonide
Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
Other Name: corticosteroid Procedure: Focal/grid laser Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups. |
- Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks [ Time Frame: baseline to 14 weeks ]Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
- Additional Treatments for Diabetic Macular Edema [ Time Frame: 14 weeks to 56-weeks ]Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.
- Change in Optical Coherence Tomography Central Subfield Thickness [ Time Frame: Baseline to 14 weeks ]
- Total Optical Coherence Tomography Retinal Volume [ Time Frame: Baseline to 14-weeks ]Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.
- Change in Visual Acuity From Baseline [ Time Frame: baseline to 56-weeks ]Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
- Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema [ Time Frame: 14 weeks to 56-weeks ]
- Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema [ Time Frame: 14 weeks to 56-weeks ]Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.
- Change in Optical Coherence Tomography Retinal Volume [ Time Frame: Baseline to 14 weeks ]Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria
- Age >= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Fellow eye (if not a study eye) meets criteria.
- Able and willing to provide informed consent. Study Eye Inclusion Criteria Subjects may have one or two study eyes. Subjects with two study eyes will be randomly assigned to receive sham injection at baseline and 4 weeks in one eye and either ranibizumab or triamcinolone in the other eye.
- Presence of severe nonproliferative or proliferative diabetic retinopathy for which investigator intends to complete panretinal photocoagulation within 49 days after randomization.
- Diabetic macular edema(DME) present on clinical exam and central subfield thickness on Optical Coherence Tomography (OCT) >250 microns, within 8 days of randomization.
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score >=24 (i.e., 20/320 or better), within 8 days of randomization.
- Media clarity, pupillary dilation, and subject cooperation sufficient to administer panretinal photocoagulation and obtain adequate fundus photographs and OCT.
- If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional focal photocoagulation.
General Exclusion Criteria
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drugs.
- Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-vascular endothelial growth factor(VEGF) or pro-VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.
Study Eye Exclusion Criteria, Study eye only:
- Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization.
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, preventing visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- History of Yttrium Aluminum Garnet capsulotomy performed within 2 months prior to randomization.
- Aphakia.
- Intraocular pressure >= 25 mmHg.
- History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion criterion).
- History of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.
- History of prior herpetic ocular infection.
- Exam evidence of ocular toxoplasmosis.
- Exam evidence of pseudoexfoliation.
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
Fellow Eye Criteria
- Intraocular pressure < 25 mmHg.
- No history of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion criterion).
- No history of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.
- No exam evidence of pseudoexfoliation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445003

Study Chair: | Alexander J. Brucker, M.D. | Scheie Eye Institute | |
Study Chair: | Joseph Googe, Jr., M.D. | Southeastern Retina Associates, P.C. |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jaeb Center for Health Research |
ClinicalTrials.gov Identifier: | NCT00445003 |
Other Study ID Numbers: |
NEI-134 U10EY018817-03 ( U.S. NIH Grant/Contract ) U10EY014229-07 ( U.S. NIH Grant/Contract ) U10EY014231-09 ( U.S. NIH Grant/Contract ) |
First Posted: | March 8, 2007 Key Record Dates |
Results First Posted: | July 13, 2011 |
Last Update Posted: | August 26, 2016 |
Last Verified: | August 2016 |
Diabetic Retinopathy Diabetic Macular Edema Lucentis Ranibizumab |
Triamcinolone Panretinal Photocoagulation Combination Therapy pdr |
Macular Edema Retinal Diseases Diabetic Retinopathy Macular Degeneration Retinal Degeneration Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide |
Ranibizumab Triamcinolone diacetate Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors |