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Trial record 3 of 3 for:    Dry Macular Degeneration | Recruiting, Not yet recruiting, Available Studies | United States, Kentucky | Adult

A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy (PRELUDE)

This study is currently recruiting participants.
Verified June 2017 by Janssen Research & Development, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02659098
First Posted: January 20, 2016
Last Update Posted: July 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
The purpose of this study is to evaluate the safety and performance profile of a modified surgical procedure and custom Delivery System and also to assess the effects on best corrected visual acuity of a single subretinal administration of CNTO 2476.

Condition Intervention Phase
Visual Acuity Geographic Atrophy Macular Degeneration Drug: CNTO 2476 6.0 x 10^4 cells Drug: CNTO 2476 3.0 x 10^5 cells Procedure: Sham-Surgical Procedure Device: Subretinal Delivery System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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.

  • 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.

  • Percentage of Participants in the Randomized Double Masked Treatment Phase Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at Month 6 [ Time Frame: Up to Month 6 ]
    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).


Secondary Outcome Measures:
  • 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).

  • 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).

  • 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).

  • Mean Change in Quality of Life From Baseline at 6 and 12 Months [ Time Frame: Baseline, Month 6 and 12 ]
    Health-related quality of life will be assessed utilizing the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and 3-item Near Vision subscale, and Short Form (36) Health Survey (SF-36) and Functional Reading Independence Index (FRI).

  • Mean Change in Reading Acuity (RA) From Baseline to 6 and 12 Months [ Time Frame: Baseline, Month 6 and 12 ]
    Minnesota reading test will be used to determine RA [measured in log of the minimum angle of resolution (logMAR)].

  • Mean Change in Number of Letters and Line Number From Baseline to 6 and 12 Months in Low Luminance Best Corrected Visual Acuity (LL BCVA) [ Time Frame: Baseline, Month 6 and 12 ]
    Low Luminance BCVA indicates the best possible vision that an eye can achieve with the use of trial frames/lenses following refraction under low luminance conditions.

  • Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months [ Time Frame: Baseline, Month 6 and 12 ]
    Contrast sensitivity will measures the sensitivity to contrast at a fixed letter size under photopic conditions.

  • Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye [ Time Frame: Month 12 ]
    Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye will be evaluated.


Estimated Enrollment: 285
Actual Study Start Date: March 21, 2016
Estimated Study Completion Date: November 30, 2022
Estimated Primary Completion Date: December 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: Double-Masked Treatment Phase: Sham-Surgical Control Group
Participants will receive a Sham surgical procedure.
Procedure: Sham-Surgical Procedure
Participants will receive a modified sham surgical procedure.
Experimental: Double-Masked Treatment Phase: Treatment Group 1
Participants will receive a single subretinal administration of CNTO 2476 6.0 x 10^4 cells in 50 microliter (mcL).
Drug: CNTO 2476 6.0 x 10^4 cells
Participants will receive a single subretinal administration of CNTO 2476 6.0 x 10^4 cells in 50 microliter (mcL) given by subretinal Delivery System.
Experimental: Double-Masked Treatment Phase: Treatment Group 2
Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL).
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.

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, followed by a randomized (study medication assigned to participants by chance), masked treatment efficacy phase for participants who have Geographic Atrophy. The study consists of 2 Phases: Open label safety Run-in Phase followed by double-masked randomized treatment Phase. The duration of participation in the study for each participant is approximately 5 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, California
Retina Institute of CA Recruiting
Arcadia, California, United States, 91007
Black Hills Regional Eye Institute Not yet recruiting
Rapid City, California, United States, 57701
California Retina Consultants Not yet recruiting
Santa Barbara, California, United States, 93103
United States, Illinois
Illinois Eye and Ear Department of Ophthalmology and Visual Sciences Recruiting
Chicago, Illinois, United States, 60612
United States, Kansas
KC Retina Associates Withdrawn
Shawnee, Kansas, United States, 66204
United States, Kentucky
Retina and Vitreous Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Not yet recruiting
Boston, Massachusetts, United States, 02114
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
The Retina Inst. William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
The Retina Institute Not yet recruiting
Saint Louis, Missouri, United States, 63144
United States, North Carolina
Duke Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
MidAtlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texas Retina Associates Recruiting
Dallas, Texas, United States, 75231
United States, Utah
Retina Associates of Utah, P.C. Withdrawn
Salt Lake City, Utah, United States, 84107
Canada, British Columbia
Vancouver Retina Research Group Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Ontario
Sunnybrook Health Sciences Center Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional 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 Submitted: December 7, 2015
First Posted: January 20, 2016
Last Update Posted: July 2, 2017
Last Verified: June 2017

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