The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates
| Registry | NCT02448446 |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 25 (Actual) |
| Sponsor | South Coast Retina Center; Carson, McBeath, Boswell, Inc. (Other); collaborators: Genentech, Inc., Doheny Image Reading Center, The Retina Partners |
| Conditions | Diabetic Macular Edema, Hard Lipid Exudates |
| Interventions | ranibizumab 0.3mg (Drug) |
| Dates | start 2015-08-01, primary completion 2018-05-01, completion 2018-05-01, first posted 2015-05-19, last updated 2021-07-08 |
| Locations | 4 sites in United States |
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All trials for Diabetic Macular Edema All trials for Hard Lipid Exudates All trials of ranibizumab 0.3mg
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diabetic macular edema treatment group (Group 1) | Active comparator | Drug: ranibizumab 0.3mg | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. |
| Diabetic macular edema and lipid treatment group (Group 2) | Active comparator | Drug: ranibizumab 0.3mg | Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Subjects will be eligible if the following criteria are met: Inclusion Criteria * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age ≥ 18 years * Type 1 or Type 2 Diabetes mellitus * Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24 * Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss * Retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: ≥290μm in women and ≥305 μm in men in the central subfield. Heidelberg Spectralis: ≥305μm in women and ≥320 μm in men in the central subfield * Lipid exudates involving the central subfield on spectral domain OCT. Exclusion Criteria Subjects who meet any of the following criteria will be excluded from this study: * Treatment for diabetic macular edema within the prior 4 months. * Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months * major ocular surgery within the prior 4 months * myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization * Pregnancy (positive pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch. * Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * Participation in another simultaneous medical investigation or trial
| Milestone | Diabetic Macular Edema Treatment Group (Group 1) | Diabetic Macular Edema and Lipid Treatment Group (Group 2) |
|---|---|---|
| Started | 13 | 12 |
| Completed | 12 | 12 |
| Not completed | 1 | 0 |
Time frame: 1 year
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Diabetic Macular Edema Treatment Group (Group 1) | 0/12 (0.0%) | 3/12 (25.0%) | 9/12 (75.0%) |
| Diabetic Macular Edema and Lipid Treatment Group (Group 2) | 0/12 (0.0%) | 2/12 (16.7%) | 9/12 (75.0%) |
| Term | Organ system | Diabetic Macular Edema Treatment Group (Group 1) | Diabetic Macular Edema and Lipid Treatment Group (Group 2) |
|---|---|---|---|
| Cysticercosis | Gastrointestinal disorders | 1/12 | 0/12 |
| Low Hemoglobin | Cardiac disorders | 1/12 | 0/12 |
| Congestive Heart Failure | Cardiac disorders | 1/12 | 0/12 |
| Kidney Infection | Infections and infestations | 1/12 | 0/12 |
| Stroke | Vascular disorders | 0/12 | 1/12 |
| Appendix Surgery | Infections and infestations | 0/12 | 1/12 |
| Heart Attack | Cardiac disorders | 0/12 | 1/12 |
| Term | Organ system | Diabetic Macular Edema Treatment Group (Group 1) | Diabetic Macular Edema and Lipid Treatment Group (Group 2) |
|---|---|---|---|
| Ear Infection | Ear and labyrinth disorders | 0/12 | 1/12 |
| Elevated Blood Pressure | Blood and lymphatic system disorders | 1/12 | 1/12 |
| Influenza | Infections and infestations | 0/12 | 3/12 |
| Decreased Liver Function | Renal and urinary disorders | 0/12 | 1/12 |
| Branch Retinal Artery Occlusion | Eye disorders | 0/12 | 1/12 |
| Headache | Vascular disorders | 1/12 | 0/12 |
| Shingles | Immune system disorders | 1/12 | 0/12 |
| Elevated Triglycerides | Blood and lymphatic system disorders | 1/12 | 0/12 |
| Central Retinal Vein Occlusion | Eye disorders | 1/12 | 0/12 |
| Sinusitis | Infections and infestations | 1/12 | 0/12 |
| Ear Infection | Ear and labyrinth disorders | 1/12 | 0/12 |
| Ocular Hypertension | Eye disorders | 1/12 | 0/12 |
| Broken Wrist | Social circumstances | 1/12 | 0/12 |
| Allergic conjunctivitis | Eye disorders | 1/12 | 0/12 |
| Right Hip Injury | Social circumstances | 1/12 | 0/12 |
| Drug Administration Error | Product Issues | 1/12 | 0/12 |
| Subconjunctival Hemhorrage | Eye disorders | 0/12 | 1/12 |
| Visual Acuity Loss | Eye disorders | 1/12 | 1/12 |
| Metastatic Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/12 | 0/12 |
| Floater | Eye disorders | 0/12 | 1/12 |
| Nausea/Vomiting | Gastrointestinal disorders | 0/12 | 1/12 |
| Facility | City | Country | Status |
|---|---|---|---|
| South Coast Retina Center; Carson, McBeath, Boswell, Inc | Huntington Beach, California | United States | |
| South Coast Retina Center; Carson, McBeath, and Boswell, Inc | Long Beach, California | United States | |
| Retina Partners | Santa Monica, California | United States | |
| South Coast Retina Center; Carson, McBeath, Boswell, Inc | Torrance, California | United States |