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Trial record 1 of 1 for:    CNTO 2476 in Subjects with Visual Acuity Impairment Associated with Geographic Atrophy Secondary to Age Related Macular Degeneration
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A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (PRELUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02659098
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Condition or disease Intervention/treatment Phase
Visual Acuity Geographic Atrophy Macular Degeneration Drug: CNTO 2476 3.0 x 10^5 cells Device: Subretinal Delivery System Phase 2

Detailed Description:
This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration
Actual Study Start Date : March 21, 2016
Estimated Primary Completion Date : December 29, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Open-Label Safety Run-in Phase: Treatment Group
Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.
Drug: CNTO 2476 3.0 x 10^5 cells
Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
Device: Subretinal Delivery System
Participants will receive CNTO 2476 by using the Delivery System.


Outcome Measures

Primary Outcome Measures :
  1. Safety Profile of the Surgical Procedure and Delivery System in Participants [ Time Frame: Up to Month 1 ]
    The number of eyes with treatment related ocular adverse events will be evaluated to determine the safety profile of suprachoroidal surgical approach and the Delivery System after drug administration in participants.

  2. Performance Profile of the Surgical Procedure and Delivery System in Participants [ Time Frame: Up to Month 1 ]
    The ability of the Delivery System to deliver CNTO 2476 cells to the subretinal space (percentage of cases with successful cell delivery) will be evaluated to determine the performance profile of suprachoroidal surgical approach and the Delivery System after drug administration in participants.


Secondary Outcome Measures :
  1. Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 12 Months [ Time Frame: Baseline to Month 12 ]
    The BCVA testing performed after refraction and under standardized photopic lighting conditions and distance using an Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR chart).

  2. Mean Change in Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months [ Time Frame: Baseline, Month 6 and 12 ]
    The BCVA testing performed after refraction and under standardized photopic lighting conditions and distance using an Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR chart).

  3. Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months [ Time Frame: Baseline, Month 6 and 12 ]
    Lesion size will be determined by fundus autofluorescence (FAF).


Eligibility Criteria

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center
  • Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye
  • Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable
  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Participant has a history of neovascular ("wet") AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening
  • Geographic atrophy secondary to any causes other than AMD in either eye
  • A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded
  • Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye
  • Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4 diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659098


Locations
United States, California
Arcadia, California, United States
Santa Barbara, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02659098     History of Changes
Other Study ID Numbers: CR106814
CNTO2476MDG2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Best Corrected Visual Acuity
Geographic Atrophy
Macular Degeneration
CNTO 2476

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical