Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.

Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.

Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Neovascular Age-Related Macular Degeneration

Drug: GB-102

Intravitreal injection of aflibercept (2 mg dose)

Aflibercept

Retinal Consultants AZ

Retinal Research Institute

California Retina Research Consultants

Retinal Diagnostic Center of Northern California

The Retina Partners

Retina Consultants of Orange County

Northern California Retina Vitreous Associates Medical Group, Inc.

West Coast Retina Medical Group, Inc.

California Retina Consultants - CRC

Bay Area Retina Associates

Specialty Retina Center

Florida Retina Institute

Retina Specialty Institute

Eye Associates of Pinellas

Southeast Retina Center

Retina Consultants of Hawaii

University Retina and Macula

Wolfe Eye Clinic - West Des Moines

Eye Associates of Northeast Louisiana

Cumberland Valley Retina Consultants

Mid Atlantic Retina Specialists

Sierra Eye Associates

Ophthalmic Consultants of Long Island

Sterling Research

Black Hills Regional Eye Institute

Retina Research Institute of Texas

Austin Retina Associates

Retina Research Center, PLLC

Retina Specialists

Retina Consultants of Houston

Strategic Clinical Research Group LLC

Piedmont Eye Center

Retina Center NW PLLC

A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Assessment of the percentage of subjects remaining rescue free at Month 10

Assessment of change in BCVA from baseline compared to the average BCVA scores (ETDRS) at Months 9 and 10

BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy
BCVA ETDRS range = 0 (worst) to 100 (best)
Assessment of change in BCVA (ETDRS letter score) from baseline at all visits

Assessment of change in CST (μm) measurement from baseline compared to the average OCT CST (μm) measurements at Months 9 and 10

CST = central subfield thickness
Assessment of change in CST (μm) measurement from baseline at all visits

CST = central subfield thickness
Assessment of change from thickest observed CST (μm) prior to enrollment (pre-enrollment baseline) compared to CST (μm) at all visits

Assessment of time to rescue treatment over 12 months of treatment

Assessment of the mean number of intravitreal injections over 12 months of treatment

Assessment of the percentage of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at Months 9 and 12 of treatment

ETDRS = early treatment of diabetic
Assessment of the proportion of subjects who gained ≥ 15 ETDRS letters at Months 9 and 12 of treatment

ETDRS = early treatment of diabetic
Assessment of the percentage of subjects who lost ≥ 15 ETDRS letters at Months 9 and 12 of treatment

Assessment of the percentage of subjects with BCVA worse than 20/200 (Snellen equivalent) at Months 9 and 12 of treatment
A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.

Graybug Vision

Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.

Low dose or high dose injected every 6 months

GB-102

Retinal Consultants of Arizona

Retina-Vitreous Associates Medical Group

Midwest Eye Institute

Texas Retina Associates

Medical Center Ophthalmology Associates

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration

Number of adverse events in total and number of subjects with an adverse event

Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)

Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method

Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)

Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)

Proportion of subjects receiving rescue medication and median time to rescue medication

Subretinal hyper reflective material (SHRM) height

Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12

Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12

Mean change from baseline in mean BCVA measured by early treatment

Mean change from baseline in sub-retinal thickness (microns) by SD-OCT

Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Sunitinib Malate: Given PO

Arm I (Sunitinib Malate)

Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies

Arm II (Placebo)

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.

Progression Free Survival (PFS)

Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Overall Survival (OS)

The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

Response Rate (RR)

The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.

Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale

The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.

Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale

Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.

Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS

Overall Study

Mark A. Socinski, M.D.

Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Stage IV Non-Small Cell Lung Cancer AJCC v7

Laboratory Biomarker Analysis

Placebo

Quality-of-Life Assessment

Sunitinib Malate

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Northeast Alabama Regional Medical Center

Providence Hospital

University of Arkansas for Medical Sciences

Veteran's Administration Medical Center

Kaiser Permanente-Anaheim

PCR Oncology

Kaiser Permanente-Baldwin Park

Kaiser Permanente-Bellflower

East Bay Radiation Oncology Center

Eden Hospital Medical Center

Valley Medical Oncology Consultants-Castro Valley

Feather River Cancer Center

Bay Area Breast Surgeons Inc

Epic Care Partners in Cancer Care

Kaiser Permanente-Fontana

Valley Medical Oncology Consultants-Fremont

Kaiser Permanente - Harbor City

Kaiser Permanente-Irvine

Long Beach Memorial Medical Center-Todd Cancer Institute

Kaiser Permanente Los Angeles Medical Center

Kaiser Permanente-Cadillac

Contra Costa Regional Medical Center

Memorial Medical Center

El Camino Hospital

Palo Alto Medical Foundation-Camino Division

Highland General Hospital

Alta Bates Summit Medical Center - Summit Campus

Bay Area Tumor Institute

Hematology and Oncology Associates-Oakland

Tom K Lee Inc

Palo Alto Medical Foundation Health Care

Kaiser Permanente - Panorama City

Valley Care Health System - Pleasanton

Valley Medical Oncology Consultants

Kaiser Permanente-Riverside

Saint Helena Hospital

Kaiser Permanente-San Diego Mission

Kaiser Permanente-San Diego Zion

Naval Medical Center -San Diego

Kaiser Permanente-San Marcos

Doctors Medical Center- JC Robinson Regional Cancer Center

Palo Alto Medical Foundation-Sunnyvale

Northbay Cancer Center

Kaiser Permanente-Woodland Hills

Poudre Valley Hospital

Hartford Hospital

Middlesex Hospital

The Hospital of Central Connecticut

Beebe Medical Center

Christiana Care Health System-Christiana Hospital

Nanticoke Memorial Hospital

MedStar Georgetown University Hospital

Sibley Memorial Hospital

Howard University Hospital

Boca Raton Comprehensive Cancer Center

Florida Hospital Memorial Medical Center

Holy Cross Hospital

Broward Health Medical Center

Jupiter Medical Center

Mount Sinai Medical Center

AdventHealth Orlando

John B Amos Cancer Center

Memorial Health University Medical Center

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Saint Anthony's Health

Rush - Copley Medical Center

Mount Sinai Hospital Medical Center

Hematology and Oncology Associates

Swedish Covenant Hospital

Presence Resurrection Medical Center

University of Chicago Comprehensive Cancer Center

Weiss Memorial Hospital

Advocate Illinois Masonic Medical Center

Presence Saint Joseph Hospital-Chicago

Decatur Memorial Hospital

AMITA Health Alexian Brothers Medical Center

Elmhurst Memorial Hospital

NorthShore University HealthSystem-Evanston Hospital

Saint Francis Hospital

Presence Saint Mary's Hospital

AMITA Health Adventist Medical Center

Garneau, Stewart C MD (UIA Investigator)

Porubcin, Michael MD (UIA Investigator)

Spector, David MD (UIA Investigator)

Trinity Medical Center

Good Samaritan Regional Health Center

AMG Oncology - Naperville

Edward Hospital/Cancer Center

West Suburban Medical Center

Swedish American Hospital

OSF Saint Anthony Medical Center

Hematology Oncology Associates of Illinois - Skokie

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

malate/atrophie

A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

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