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
The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy
RRR is a phase II, randomized, multicenter, clinical study to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy. Subjects will be randomized into one of 3 arms; intravitreal (IVT) monthly vs. ranibizumab treatment administered IVT monthly combined with peripheral targeted photocoagulation vs. ranibizumab treatment administered IVT for three months followed by as needed treatment of ranibizumab combined with peripheral targeted photocoagulation over 48 weeks. From week 52 to week 101, all 3 treatment arms will employ a treat and extend protocol for IVT ranibizumab treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks. Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on spectral domain (SD)-optical coherence tomography (OCT). The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again. |
|
| Cohort B | Experimental | Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. |
|
| Cohort C | Experimental | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg ranibizumab | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart. | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | 104 weeks | |
| Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | 104 weeks | |
Not provided
Inclusion Criteria
Subjects will be eligible to participate if the following criteria are met:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
Pregnancy (verified by positive pregnancy test) or lactation
Premenopausal women not using adequate methods of contraception. The following are considered effective means of contraception: surgical sterilization, 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 any other simultaneous medical investigation or trial
Previous participation in any studies involving investigational drugs within 30 days before Day 0 (excluding vitamins and minerals).
History of allergy fluorescein, not amenable to treatment
Previous intravitreal treatment with any anti-vascular endothelial growth factor (VEGF) drug within 60 days of Day 0
Previous intravitreal or subconjunctival treatment with cortical steroids within 90 days of Day 0
History of vitrectomy
History of treatment with more than one form of radiation to the eye (e.g. proton beam therapy and plaque therapy).
Subjects who have more than 7 disc diameters of ischemia in the central macula that would hinder visual acuity improvement
History of panretinal photocoagulation treatment in the study eye.
Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could:
Active intraocular inflammation (grade 2+ or above) in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye.
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
Aphakia or absence of the posterior capsule in the study eye.
Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0.
Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) > 30 mmHg despite treatment with anti-glaucoma medication).
History of glaucoma-filtering surgery in the study eye
History of corneal transplant in the study eye
Uncontrolled blood pressure (defined as systolic and/or diastolic > 180/110 mmHg while subject is seated). If the subject's initial reading exceeds these values, a second reading may be taken at least 30 minutes later. If the subject requires antihypertensive medication, the subject can become eligible if medication is taken continuously for at least 14 days prior to Day 0 and blood pressure is less that 180/110 mmHg.
New diagnosis of atrial fibrillation not managed by subject's primary care physician or cardiologist within 3 months of Day 0.
History of stroke within the last 3 months of Day 0.
History of myocardial infarction within 3 months of Day 0.
History of other disease, metabolic dysfunction, or physical examination finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the subject at high risk for treatment complications.
Current treatment for active systemic infection
Active malignancy other than uveal melanoma
Presence of metastases
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy C Schefler, MD | Retina Consultants Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Retina Associates | Dallas | Texas | 75231 | United States | ||
| Retina Consultants of Houston/The Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12466159 | Background | Jampol LM, Moy CS, Murray TG, Reynolds SM, Albert DM, Schachat AP, Diddie KR, Engstrom RE Jr, Finger PT, Hovland KR, Joffe L, Olsen KR, Wells CG; Collaborative Ocular Melanoma Study Group (COMS Group). The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: IV. Local treatment failure and enucleation in the first 5 years after brachytherapy. COMS report no. 19. Ophthalmology. 2002 Dec;109(12):2197-206. doi: 10.1016/s0161-6420(02)01277-0. | |
| 11158813 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks. Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again. 0.5 mg ranibizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline to W48 |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2015 | Feb 5, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Targeted Retinal Photocoagulation (TRP) |
| Procedure |
TRP to areas of retinal ischemia |
|
| Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. |
| 104 weeks |
| Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline. | Spectral-domain optical coherence tomography (SD-OCT) is a common imaging modality used to visualize the layers of the macula. Central mean thickness (CMT) is the length in microns from the internal limiting membrane to Bruch's membrane. | 104 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| Retina Consultants of Houston | Katy | Texas | 77494 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Background |
| Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1. |
| 10326957 | Background | Gunduz K, Shields CL, Shields JA, Cater J, Freire JE, Brady LW. Radiation retinopathy following plaque radiotherapy for posterior uveal melanoma. Arch Ophthalmol. 1999 May;117(5):609-14. doi: 10.1001/archopht.117.5.609. |
| 23813109 | Background | Finger PT, Chin KJ. High-dose (2.0 mg) intravitreal ranibizumab for recalcitrant radiation retinopathy. Eur J Ophthalmol. 2013 Nov-Dec;23(6):850-6. doi: 10.5301/ejo.5000333. Epub 2013 Jun 28. |
| 20142553 | Background | Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. No abstract available. |
| 21277107 | Background | Finger PT, Chin KJ. Antivascular endothelial growth factor bevacizumab for radiation optic neuropathy: secondary to plaque radiotherapy. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):789-98. doi: 10.1016/j.ijrobp.2010.11.075. Epub 2011 Jan 27. |
| 21218391 | Background | Finger PT, Mukkamala SK. Intravitreal anti-VEGF bevacizumab (Avastin) for external beam related radiation retinopathy. Eur J Ophthalmol. 2011 Jul-Aug;21(4):446-51. doi: 10.5301/EJO.2011.6213. |
| 17891015 | Background | Mason JO 3rd, Albert MA Jr, Persaud TO, Vail RS. Intravitreal bevacizumab treatment for radiation macular edema after plaque radiotherapy for choroidal melanoma. Retina. 2007 Sep;27(7):903-7. doi: 10.1097/IAE.0b013e31806e6042. |
| 18313522 | Background | Finger PT. Radiation retinopathy is treatable with anti-vascular endothelial growth factor bevacizumab (Avastin). Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):974-7. doi: 10.1016/j.ijrobp.2007.11.045. |
| 17562985 | Background | Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. doi: 10.1001/archopht.125.6.751. |
| 18698298 | Background | Gupta A, Muecke JS. Treatment of radiation maculopathy with intravitreal injection of bevacizumab (Avastin). Retina. 2008 Jul-Aug;28(7):964-8. doi: 10.1097/IAE.0b013e3181706302. |
| 16205566 | Background | Shields CL, Demirci H, Dai V, Marr BP, Mashayekhi A, Materin MA, Manquez ME, Shields JA. Intravitreal triamcinolone acetonide for radiation maculopathy after plaque radiotherapy for choroidal melanoma. Retina. 2005 Oct-Nov;25(7):868-74. doi: 10.1097/00006982-200510000-00009. |
| 15923510 | Background | Finger PT, Kurli M. Laser photocoagulation for radiation retinopathy after ophthalmic plaque radiation therapy. Br J Ophthalmol. 2005 Jun;89(6):730-8. doi: 10.1136/bjo.2004.052159. |
| 19277244 | Background | Kinyoun JL. Long-term visual acuity results of treated and untreated radiation retinopathy (an AOS thesis). Trans Am Ophthalmol Soc. 2008;106:325-35. |
| 9709753 | Background | Hykin PG, Shields CL, Shields JA, Arevalo JF. The efficacy of focal laser therapy in radiation-induced macular edema. Ophthalmology. 1998 Aug;105(8):1425-9. doi: 10.1016/S0161-6420(98)98023-X. |
| 17021319 | Background | Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655. |
| 17021318 | Background | Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
| 18222192 | Background | Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008 Feb;145(2):239-248. doi: 10.1016/j.ajo.2007.10.004. |
| 19118696 | Background | Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009 Jan;116(1):57-65.e5. doi: 10.1016/j.ophtha.2008.10.018. |
| 19643495 | Background | Boyer DS, Heier JS, Brown DM, Francom SF, Ianchulev T, Rubio RG. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009 Sep;116(9):1731-9. doi: 10.1016/j.ophtha.2009.05.024. Epub 2009 Jul 29. |
| 34463842 | Derived | Yu HJ, Fuller D, Anand R, Fuller T, Munoz J, Moore C, Kim RS, Schefler AC; RRR Study Group. Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial. Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):47-54. doi: 10.1007/s00417-021-05281-2. Epub 2021 Aug 31. |
| FG001 | Cohort B | Subject's receive monthly treatment of intravitreal (IVT) 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
| FG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
| COMPLETED |
|
| NOT COMPLETED |
|
| Baseline to W104 |
|
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks. Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again. 0.5 mg ranibizumab |
| BG001 | Cohort B | Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
| BG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years | Eyes |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants | Participants |
| |||||||||||||||
| Best-Corrected Visual Acuity | Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart. | Mean | Full Range | letters | Participants |
|
| 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 | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0. | Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart. | Subjects analyzed only include those that completed the W104 visit. | Posted | Mean | Standard Deviation | letters | 104 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Mean Number of Intravitreal Injections Required Per Subject Per Cohort. | Posted | Mean | Full Range | injections | 104 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Retinal Hemorrhage at 104 Weeks. | Posted | Count of Participants | Participants | 104 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104. | Posted | Count of Participants | Participants | 104 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline. | Spectral-domain optical coherence tomography (SD-OCT) is a common imaging modality used to visualize the layers of the macula. Central mean thickness (CMT) is the length in microns from the internal limiting membrane to Bruch's membrane. | Posted | Mean | Standard Deviation | micrometers | 104 weeks |
|
Baseline through 104 weeks
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 | Cohort A | Subject's will receive monthly treatment of an intravitreal injection of 0.5 mg ranibizumab for 48 weeks. Starting at week 52, subject's will enter a treat & extend regime, if a subject achieves a "dry" macula. For a macula to be considered "dry" persistent or recurrent fluid must be resolved on SD-OCT. The interval between injections will not exceed 12 weeks. After a subject is extended beyond 4-weeks & develops recurrent disease activity, the eye is treated & the treatment interval for the next visit is reduced by 1 week, compared to the previous treatment interval. The interval between treatments will be reduced by 1-week intervals until a dry macula is again established. Once a dry macula is again achieved, the interval between visits will be extended by 1-week intervals again. 0.5 mg ranibizumab | 0 | 8 | 1 | 8 | 3 | 8 |
| EG001 | Cohort B | Subject's receive monthly treatment of IVT of 0.5 mg ranibizumab for 48 weeks. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia based on 120° or greater wide field angiography. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia | 0 | 16 | 2 | 16 | 7 | 16 |
| EG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia | 1 | 16 | 5 | 16 | 6 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Chronic Diastolic Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Acute Chronic Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Broken Wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Central Retinal Artery Occlusion | Eye disorders | Non-systematic Assessment |
| ||
| Chronic Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Recurrence of Choroidal Melanoma | Eye disorders | Non-systematic Assessment |
| ||
| Metastatic Uveal Melanom | Eye disorders | Systematic Assessment |
| ||
| Pancreatitis | Endocrine disorders | Systematic Assessment |
| ||
| Worsening of Hypertension | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Abrasion | Eye disorders | Non-systematic Assessment |
| ||
| Dry Eyes | Eye disorders | Non-systematic Assessment |
| ||
| Increased Cup-to-Disc Rratio | Eye disorders | Non-systematic Assessment |
| ||
| Ocular Irritation | Eye disorders | Non-systematic Assessment |
| ||
| Ocular Pain | Eye disorders | Non-systematic Assessment |
| ||
| Posterior Capsular Opacification | Eye disorders | Non-systematic Assessment |
| ||
| Posterior Vitreous Detachment | Eye disorders | Non-systematic Assessment |
| ||
| Subconjunctival Hemorrhage | Eye disorders | Non-systematic Assessment |
| ||
| Worsening of Cataracts | Eye disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy C. Schefler | Retina Consultants of Texas | (713) 524-3434 | acsmd@retinaconsultantstexas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2020 | Mar 24, 2021 | SAP_001.pdf |
| 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
|
|
| OG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
|
|
| OG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
|
|
| OG002 | Cohort C | Subject's will receive 3 consecutive monthly doses of IVT 0.5 mg ranibizumab followed by PRN treatment with 0.5 mg ranibizumab intravitreal injection. 1 week after the initial dose of IVT ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) to areas of peripheral retinal ischemia. After the first session of TRP, subjects will have a repeat wide field angiogram at 12 weeks & 24 weeks & will receive additional TRP as needed (PRN) to areas of peripheral retinal ischemia. Starting at week 52, subject's will enter a treat & extend regime as described in cohort A. 0.5 mg ranibizumab Targeted Retinal Photocoagulation (TRP): TRP to areas of retinal ischemia |
|
|