Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions Clinical Trial
— WAVEOfficial title:
A Phase IV Open Label Trial of the Safety, Tolerability and Efficacy of 0.5mg Ranibizumab Intravitreal Injections Combined With Wide Field Angiography Guided Panretinal Photocoagulation vs. 0.5mg Ranibizumab Intravitreal Injection Monotherapy in Subjects With Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion Who Incompletely Respond to at Least 2 Consecutive Intravitreal Injections in the Past 4 Months.
To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to standard of care
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age > 18 years - Visual acuity between 20/25 and 20/800, ETDRS best corrected visual acuity - Ability to provide written informed consent and comply with study assessments for the full duration of the study Patients previously treated with any ITV anti-VEGF: • With at least 2 consecutive monthly intravitreal injections of anti-VEGF medications with presence of persistent or recurrent macular edema in the past 4 months Exclusion Criteria: - IOP over 30 mm Hg - Any previous retinal laser photocoagulation to the study eye - Previous intravitreal injection in the study eye of any corticosteroid treatment - Previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery) - Intracapsular cataract extraction - Any previous radiation treatments to head/neck that the principal or sub investigator feels is clinically relevant - Inability to assess iris or angle neovascularization (corneal opacity precluding gonioscopy) - Significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study - Significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy) - Participation in another simultaneous medical investigator or trial - Ocular disorders or concurrent disease in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention, including history of retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., DME, AMD, ocular histoplasmosis, or pathologic myopia) - Structural damage to the center of the macula in the study eye prior to CRVO, HRVO and BRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s) - Vitreomacular traction or clinically significant epiretinal membrane in the study eye evident biomicroscopically or by OCT (vitreomacular attachment OK) - Infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection - Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia (For patients who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than -8 diopters myopia is not allowed) - Uncontrolled Blood pressure: defined as systolic pressure > 180mmHg and/or diastolic pressure of >110 mm Hg (sitting) during the screening period - Uncontrolled diabetes mellitus - Renal failure requiring dialysis or renal transplant - 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 IUD, or contraceptive hormone implant or patch. - History of other disease, metabolic dysfunction, physical examination finding, or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications - History of allergy to fluorescein, not amenable to treatment - Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed by the principal investigator (PI) and/or the sub-investigator. - History of allergy to humanized antibodies or any component of the ranibizumab formulation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Retina Consultants of Houston/The Medical Center | Houston | Texas |
| United States | Retina Consultants of Houston | Katy | Texas |
| United States | Retina Consultants of Houston | The Woodlands | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Charles C Wykoff, PhD, MD | Genentech, Inc. |
United States,
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total number of intravitreal injections in a 12 month period | Assess the number of intravitreal injections over 12 months. | 12 months | No |
| Primary | Visual Acuity | Evaluate the mean change from baseline in ETDRS BCVA at 12 months. | 12 month period | No |
| Secondary | Retinal Ischemia | Quantify change in area of perfused and ischemic retina. | 12 month period | No |
| Secondary | Foveal Avascular Zone | Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram | 12 months | No |
| Secondary | Adverse Events | Incidence and severity of adverse events (ocular and non-ocular). | 12 months | Yes |
| Secondary | Neovascularization of the Iris, Optic Nerve and Elsewhere | Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere. | 12 months | No |
| Secondary | Central Foveal Outcome | Mean change in Central Foveal Volume on High Resolution OCT. | 12 months | No |
| Secondary | Aqueous VEG F Levels | VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit. | 12 Months | No |
| Secondary | Visual Field | Goldman Visual Field changes at 6 and 12 months from baseline. | 6 and 12 Months | No |