Roche CHROMA Trial

Active Clinical Trials // Feb 14 2017

sponsored by Roche

A Phase III, multicenter, randomized, double-masked, sham-controlled study to assess the efficacy and safety of lampalizumab administered intravitreally to patients with geographic atrophy secondary to age-related macular degeneration.

Phase III

Sponsor(s): F. Hoffman-La Roche Ltd

Principal Investigator: Barbara Blodi, MD

Study Coordinator: Chris Smith

Description of Study

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of a 10-mg dose of lampalizumab administered Q4W or Q6W by intravitreal injections for approximately 2 years (96 weeks) treatment period in patients with GA secondary to age-related macular degeneration (AMD).

Number of Patients

The study will randomize approximately 936 patients at approximately 125 investigational sites globally.

Target Population

Inclusion Criteria

Patients must meet the following criteria for study entry:

  1. General Inclusion Criteria

– Age ≥50 years

– For women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 30 (±7) days after the last dose of study treatment

– Ability and willingness to undertake all scheduled visits and assessments

– Valid CFI profile biomarker result (i.e., CFI profile biomarker-positive or CFI profile biomarker-negative)

  1. Ocular Inclusion Criteria: Study Eye

– BCVA of 20/100 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m

– Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV

– The total GA lesion size ≥2.54 mm2 (approximately ≥1 disc area [DA]) and ≤17.78 mm2 (approximately ≤7 DA) and must reside completely within the FAF imaging field (Field 2−30 degree image centered on the fovea)

– If GA is multifocal, at least 1 focal lesion must be ≥1.27 mm2 (approximately ≥0.5 DA)

– Presence of hyperautofluorescence of either banded or diffuse patterns adjacent to the area of GA

– Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

  1. Ocular Inclusion Criteria: Non-study Eye

– GA secondary to AMD with no evidence of prior or active CNV

– GA lesion must reside completely within the FAF imaging field (Field 2-30 degree image centered on the fovea)

Exclusion Criteria

  1. GA Characteristics Exclusion Criteria

– GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])

  1. Ocular Exclusion Criteria: Study Eye

– History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD

– Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy

– Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy

– History of prophylactic subthreshold laser treatment for AMD

– Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.

  1. Ocular Exclusion Criteria: Both Eyes

– Previous treatment with eculizumab or participation in eculizumab studies

– Previous treatment of either eye with lampalizumab

– Previous treatment with fenretinide or participation in fenretinide studies

  1. d) Ocular Exclusion Criteria: Concurrent Ocular Conditions

– Retinal pigment epithelium (RPE) tear that involves the macula in either eye

– Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could do either of the following:

– Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition

– If allowed to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of BCVA during the study period

– Active uveitis and/or vitritis (grade trace or above) in either eye

– History of idiopathic or autoimmune-associated uveitis in either eye

– Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

– Current vitreous hemorrhage in the study eye

– History of retinal detachment or macular hole (Stage 3 or 4) in the study eye

– Aphakia or absence of the posterior capsule in the study eye

– Previous violation of the posterior capsule in the study eye unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation

– Spherical equivalent of the refractive error in the study eye demonstrating >8 diopters of myopia

– For patients who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye should not have exceeded 8 diopters of myopia.

– Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 1

– Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] ≥30 mm Hg despite treatment with anti-glaucoma medication)

– History of glaucoma-filtering surgery in the study eye

– History of corneal transplant in the study eye

– Proliferative diabetic retinopathy in either eye

– Prior or active CNV in either eye

– Central serous retinopathy in either eye

– History of recurrent infectious or inflammatory ocular disease

  1. e) Concurrent Systemic Conditions Exclusion Criteria

– Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >110 mm Hg while patient is sitting)

– History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications

– Treatment for active systemic infection

– Predisposition or history of increased risk of infection (i.e., history of splenectomy or chronic immunosuppression)

– Active malignancy

– History of allergy to fluorescein that is not amenable to treatment

– Inability to comply with study or follow-up procedures

– Inability to obtain color fundus photograph (CFP), FAF, and fluorescein angiogram (FA) of sufficient quality to be analyzed and graded by the central reading center

– Previous participation in any studies of investigational drugs within 3 months preceding Day 1 (excluding vitamins and minerals)

– Women who are pregnant or lactating or intending to become pregnant during the study

– Women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 21 days prior to initiation of study treatment.

Length of Study

The duration of the study is approximately 2 years (96 weeks) after the last patient is randomized to the study.

Please contact the study coordinator Chris Smith with questions 608-263-7169