Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
The WAVE trial is a phase IV, open label, 12-month trial of intravitreal ranibizumab 0.5 mg in patients (n=30) with ischemic CRVO, HRVO and BRVO who have been previously treated with ranibizumab or any other anti-VEGF intravitreal injection therapy, who are incomplete responders to 2 or more consecutive intravitreal anti-VEGF injections in the past 4 months. Randomization is 1:4, 1=control, ranibizumab only, 4=treatment arm. In total, 6 subjects will be randomized to control and 24 randomized to treatment arm.
Cohort 1- 24 Subjects previously treated Patients will receive 6 doses of ranibizumab 0.5 mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined retreatment criteria for up to 11 total injections.
Wide field angiography guided peripheral targeted-retinal photocoagulation (TRP), will be divided into 2 sessions if needed, one at the 2 weeks post injection visit and another later at M4/V7, if repeat wide field angiogram indicates areas not sufficiently treated in the first TRP session
Cohort 2- 6 Subjects, previously treated patients will receive 6 doses of ranibizumab 0.5 mg, followed by PRN intravitreal injection of ranibizumab 0.5 mg based on pre-defined retreatment criteria for up to 11 total injections.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Pan Retinal laser combined with 0.5mg ranibizumab | Experimental | Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina. |
|
| Ranibizumab 0.5mg | Active Comparator | Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5mg Ranibizumab | Drug | intravitreal injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Intravitreal Injections Over a 12 Month Period | Assess the number of intravitreal injections over 12 months. | 12 months |
| Visual Acuity | Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. | 12 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Ischemia | Quantify change in area of perfused and ischemic retina. | 12 month period |
| Foveal Avascular Zone | Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles C Wykoff, PhD, MD | Retina Consultants Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Houston/The Medical Center | Houston | Texas | 77030 | United States | ||
| Retina Consultants of Houston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5763217 | Background | Armaly MF. Ocular pressure and visual fields. A ten-year follow-up study. Arch Ophthalmol. 1969 Jan;81(1):25-40. doi: 10.1001/archopht.1969.00990010027005. No abstract available. | |
| 12470137 | Background | Boyd SR, Zachary I, Chakravarthy U, Allen GJ, Wisdom GB, Cree IA, Martin JF, Hykin PG. Correlation of increased vascular endothelial growth factor with neovascularization and permeability in ischemic central vein occlusion. Arch Ophthalmol. 2002 Dec;120(12):1644-50. doi: 10.1001/archopht.120.12.1644. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab | Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina. 0.5mg Ranibizumab: intravitreal injections Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label
Not provided
| Targeted Pan Retinal Photocoagulation | Procedure | Targeted Pan Retinal Photocoagulation based on wide field angiography |
|
|
| 12 months |
| Adverse Events | Incidence and severity of adverse events (ocular and non-ocular). | 12 months |
| Neovascularization of the Iris, Optic Nerve and Elsewhere | Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere. | 12 months |
| Central Foveal Outcome | Mean change in Central Foveal Volume on High Resolution OCT. | 12 months |
| Aqueous VEGF Levels | VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit. | 12 Months |
| Visual Field | Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots. | 6 and 12 Months |
| Katy |
| Texas |
| 77494 |
| United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| 20381871 | Background | Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9. |
| 21715011 | Background | Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG. Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study. Ophthalmology. 2011 Oct;118(10):2041-9. doi: 10.1016/j.ophtha.2011.02.038. Epub 2011 Jun 29. |
| 9097789 | Background | A randomized clinical trial of early panretinal photocoagulation for ischemic central vein occlusion. The Central Vein Occlusion Study Group N report. Ophthalmology. 1995 Oct;102(10):1434-44. |
| 9109757 | Background | Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006. |
| 8827967 | Background | Christen WG, Glynn RJ, Manson JE, Ajani UA, Buring JE. A prospective study of cigarette smoking and risk of age-related macular degeneration in men. JAMA. 1996 Oct 9;276(14):1147-51. |
| 2320579 | Background | Conn G, Bayne ML, Soderman DD, Kwok PW, Sullivan KA, Palisi TM, Hope DA, Thomas KA. Amino acid and cDNA sequences of a vascular endothelial cell mitogen that is homologous to platelet-derived growth factor. Proc Natl Acad Sci U S A. 1990 Apr;87(7):2628-32. doi: 10.1073/pnas.87.7.2628. |
| 2478587 | Background | Connolly DT, Heuvelman DM, Nelson R, Olander JV, Eppley BL, Delfino JJ, Siegel NR, Leimgruber RM, Feder J. Tumor vascular permeability factor stimulates endothelial cell growth and angiogenesis. J Clin Invest. 1989 Nov;84(5):1470-8. doi: 10.1172/JCI114322. |
| 2584205 | Background | Connolly DT, Olander JV, Heuvelman D, Nelson R, Monsell R, Siegel N, Haymore BL, Leimgruber R, Feder J. Human vascular permeability factor. Isolation from U937 cells. J Biol Chem. 1989 Nov 25;264(33):20017-24. |
| 1312256 | Background | de Vries C, Escobedo JA, Ueno H, Houck K, Ferrara N, Williams LT. The fms-like tyrosine kinase, a receptor for vascular endothelial growth factor. Science. 1992 Feb 21;255(5047):989-91. doi: 10.1126/science.1312256. |
| 2483144 | Background | Hayreh SS, Klugman MR, Podhajsky P, Kolder HE. Electroretinography in central retinal vein occlusion. Correlation of electroretinographic changes with pupillary abnormalities. Graefes Arch Clin Exp Ophthalmol. 1989;227(6):549-61. doi: 10.1007/BF02169451. |
| 35976232 | Derived | Fan W, Fleming A, Hemert JV, Wykoff CC, Brown DM, Robertson G, Wang K, Falavarjani KG, Sadda SR, Ip M. RETINAL VASCULAR BED AREA IN EYES WITH RETINAL VEIN OCCLUSION ON ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY: WAVE Study. Retina. 2022 Oct 1;42(10):1883-1888. doi: 10.1097/IAE.0000000000003549. |
| 28318636 | Derived | Wykoff CC, Ou WC, Wang R, Brown DM, Cone C, Zamora D, Le RT, Sagong M, Wang K, Sadda SR; WAVE Study Group. Peripheral Laser for Recalcitrant Macular Edema Owing to Retinal Vein Occlusion: The WAVE Trial. Ophthalmology. 2017 Jun;124(6):919-921. doi: 10.1016/j.ophtha.2017.01.049. Epub 2017 Mar 18. No abstract available. |
| FG001 | Ranibizumab 0.5mg | Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg. 0.5mg Ranibizumab: intravitreal injections |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab | Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina. 0.5mg Ranibizumab: intravitreal injections Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography |
| BG001 | Ranibizumab 0.5mg | Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg. 0.5mg Ranibizumab: intravitreal injections |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| RVO Subtype | Count of Participants | Participants |
| ||||||||||||||||
| Prior Anti-VEGF Injections | Mean | Full Range | injections |
| |||||||||||||||
| ETDRS BCVA Letters | Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. | Mean | Full Range | ETDRS BCVA Letters |
| ||||||||||||||
| Central Retinal Thickness | Mean | Full Range | micrometers |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Intravitreal Injections Over a 12 Month Period | Assess the number of intravitreal injections over 12 months. | Posted | Mean | Full Range | injections | 12 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Visual Acuity | Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. | 1 patient withdrew from the study before month 12 | Posted | Mean | Standard Error | ETDRS BCVA Letters | 12 month period |
| ||||||||||||||||||||||||||||||
| Secondary | Retinal Ischemia | Quantify change in area of perfused and ischemic retina. | Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed. | Posted | 12 month period |
| |||||||||||||||||||||||||||||||||
| Secondary | Foveal Avascular Zone | Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram | Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed. | Posted | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Adverse Events | Incidence and severity of adverse events (ocular and non-ocular). | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Neovascularization of the Iris, Optic Nerve and Elsewhere | Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere. | Posted | Number | percentage of patients | 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Central Foveal Outcome | Mean change in Central Foveal Volume on High Resolution OCT. | 1 patient withdrew from the study before month 12 | Posted | Mean | Standard Deviation | cubic millimeters | 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Aqueous VEGF Levels | VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit. | Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed. | Posted | 12 Months |
| |||||||||||||||||||||||||||||||||
| Secondary | Visual Field | Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots. | Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14) | Posted | Mean | Standard Error | square degrees | 6 and 12 Months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab | Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina. 0.5mg Ranibizumab: intravitreal injections Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography | 2 | 24 | 17 | 24 | ||
| EG001 | Ranibizumab 0.5mg | Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg. 0.5mg Ranibizumab: intravitreal injections | 0 | 6 | 2 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhoids with rectal bleeding | Vascular disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma suspect | Eye disorders | Systematic Assessment |
| ||
| Cataract progression | Eye disorders | Systematic Assessment |
| ||
| Visual distortion | Eye disorders | Systematic Assessment |
| ||
| Posterior vitreous detachment | Eye disorders | Systematic Assessment |
| ||
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Epiretinal membrane | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles C Wykoff, PhD, MD | Retina Consultants of Houston | 713-524-3434 | ccwmd@houstonretina.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| BRVO |
|
| HRVO |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|