Visual AcuityPhase 2NCT02895815
Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
A Phase 2 study testing CNTO 2476 (6.0 * 10^4 cells) and CNTO 2476 (3.0 * 10^5 cells) in people with Visual Acuity and Geographic Atrophy, run by Janssen Pharmaceutical K.K..
Trial summary
The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Visual Acuity, Geographic Atrophy, Macular Degeneration
- What is being tested?
- CNTO 2476 (6.0 * 10^4 cells) and CNTO 2476 (3.0 * 10^5 cells)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2018to 19 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 28 days prior to initial randomization by the central reading center using fundus photographs and including the following; a) The study eyes must have at least 1 GA lesion that involves the fovea, and a Macular Photocoagulation Study (MPS) disc areas (DA) of >= 1 and <= 7 (1 Macular Photocoagulation Study Disc Area (MPS DA equivalent to 2.54 millimeter (mm)^2 on the retina) determined by screening images of fundus autofluorescence photographs as calculated by the reading center. If GA is multifocal, at least 1 lesion must be >= 0.5 DA, b) GA must be able to be photographed in its entirety and may be contiguous with peripapillary atrophy, c) Retinal photographs, fundus autofluorescence images, and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained d) The imaging center must be able to delineate and confirm peripapillary atrophy with fundus photography and fundus autofluorescence, e) Images must include the central field 1, 2, and 3 field images as defined by the University of Wisconsin standards as well as a supero temporal image to capture the subretinal injection area if possible
- Female participants must be postmenopausal with last menses 12 months prior, or longer without medical reasons (example, treatment with a drug), or a measured follicle stimulating hormone >= 26 milli-international units per milliliter (mIU/mL)
- Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 (Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR value 0.6-1.6). BCVA in the study eye must be worse than the BCVA in the fellow eye at screening
- Male participants must be sterile or willing to use 2 approved methods of contraception from first day postoperatively to 3 months postoperatively
Who cannot join
- Participant has a history of neovascular ("wet") AMD in the study eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if antivascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to screening
- A diagnosis of glaucoma with an intraocular pressure (IOP) >= 25 millimeter of mercury (mm Hg) 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)
- Myopia >-8 diopters and participants with >4 diopters of astigmatism, and >+10 diopters of hyperopia
- Previous vitrectomy, retinal detachment repair, submacular surgery, other surgical interventions targeting AMD, scleral buckling or glaucoma filtration surgery or any other extraocular or orbital procedure in the study eye that, in the opinion of the surgeon, would hamper the suprachoroidal cannulation procedure in the study eye
About this study
Official title: A Phase 2, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).
Read the detailed description
This is a Phase 2 study to evaluate the efficacy and safety of a single subretinal administration of CNTO 2476 compared with the untreated control group, as well as to assess the safety and usability profile of the procedure and the device for cell therapy delivery in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD). The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 month, 12 months and every 6 month thereafter. Participant's safety will be monitored throughout the study.
- Conditions
- Visual Acuity, Geographic Atrophy, Macular Degeneration
- Being tested
- CNTO 2476 (6.0 * 10^4 cells), CNTO 2476 (3.0 * 10^5 cells)
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 2476 (6.0 * 10^4 cells)Combination product
Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit [SRAK-02 kit] and third arm accessory).
CNTO 2476 (3.0 * 10^5 cells)Combination product
Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory).
| Study group | Role | What they receive |
|---|---|---|
| CNTO 2476 (6.0 * 10^4 cells) | Experimental | Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 microliter (mcL) given by subretinal delivery system. Receives: Combination Product: CNTO 2476 (6.0 * 10^4 cells) |
| CNTO 2476 (3.0 * 10^5 cells) | Experimental | Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system. Receives: Combination Product: CNTO 2476 (3.0 * 10^5 cells) |
| Control Group | No intervention | Participants will undergo observations without surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at 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). The ETDRS chart at 4 meters is considered the 'gold standard' for visual acuity testing in clinical research for its physical and statistical properties.
Measured: Month 6
Secondary outcomes (20)
Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month
Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month
Measured: Baseline and Month 12
Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months
Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months
Measured: Baseline, Month 6 and 12
Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months
Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months
Measured: Baseline, Month 6 and 12
Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months
The area of GA is determined based primarily on fundus autofluorescence (FAF) as well as fluorescein angiography and fundus photography.
Measured: Baseline, Month 6 and 12
Mean Change in Reading Acuity (RA) From baseline to 6 and 12 Months
Minnesota reading test will be used to determine RA measured in log of the minimum angle of resolution (logMAR).
Measured: Baseline, Month 6 and 12
Mean Change in Maximum Reading Speed (MRS) From Baseline to 6 and 12 Months
Minnesota reading test will be used to determine maximum reading speed (MRS, [measured in characters per minute]).
Measured: Baseline, Month 6 and 12
Mean Change in Critical Print Size (CPS) From Baseline to 6 and 12 Months
Minnesota reading test will be used to determine CPS measured in log of the minimum angle of resolution (logMAR).
Measured: Baseline, Month 6 and 12
Mean Change in Low Luminance Best Corrected Visual Acuity (LL BCVA) Letters From Baseline to 6 and 12 Months
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.
Measured: Baseline, Month 6 and 12
Percentage of Participants With Gain of >= 15 Letters in LL BCVA From Baseline to 6 and 12 Months
Percentage of Participants With Gain of >= 15 Letters in LL BCVA From Baseline to 6 and 12 Months
Measured: Baseline, Month 6 and 12
Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months
Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months
Measured: Baseline, Month 6 and 12
Number of Participants With Significant Changes in Retinal Morphology
Number of Participants With Significant Changes in Retinal Morphology
Measured: Baseline, Month 6 and 12
Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye
Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye
Measured: Baseline, Month 6 and 12
Percentage of Participants who Achieved Technical Success in the Active Drug Group
Percentage of participants who achieved technical success in the active drug group will be evaluated and the criteria that must be met to achieve technical success are :1) The device was accessible to the suprachoroidal space, 2) Micro needle reached to the subretinal space, 3) When study drug injected into the subretinal space a) No retinal perforation was directly visualized by the surgeon following the formation of the bleb in the subretinal space after injecting the balanced salt solution (BSS) Plus, b) When 50 microliter (mcL) of study drug was administered subretinally, the creation of an enlarged bleb in the subretinal space is visualized by the surgeon, 4) Micro needle and the device were removed.
Measured: 6 Months
Percentage of Participants who Achieved Procedural Success in the Active Drug Group
Percentage of participants who achieved procedural success in the active drug group will be evaluated and the criteria that must be met to achieve procedural success : 1) Achievement of technical success, 2) Endophthalmitis, significant choroidal hemorrhage, leakage of cells or other need for vitrectomy, retinal detachment, and failure to deliver cells did not occur, 3) No device malfunction.
Measured: Month 6 and 12
Number of Participants with Ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study treatment, device and surgical procedure-related ocular AEs and SAEs will be reported.
Measured: Up to Long term Follow up (Month 36)
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Short Form (36) Health Survey
SF-36 is scored to produce 8 subscales (Physical Functioning, Role Limitations-Physical, Bodily Pain, General Health Perceptions, Vitality, Social Functioning, Role Limitations- Emotional, and Mental Health) and 2 summary scores (Physical Component Summary and Mental Component Summary).
Measured: Baseline, Month 6 and 12
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health Related Quality of Life as Assessed by Functional Reading Index Questionnaire (FRI)
The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.
Measured: Baseline, Month 6 and 12
Incidence of Anti-CNTO 2476 Antibodies
Number of participants who develop antibodies.
Measured: Baseline, Day 7 and 15, Month 2, 3 and 6
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Score
The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
Measured: Baseline, Month 6 and 12
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Near Vision Subscale Score
A 3-item Near Vision subscale score of National Eye Institute will evaluate quality of life. Response to each question converted to 0-100 score. Each subscale, total score equal to average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
Measured: Baseline, Month 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start9 Apr 2018 (estimated)
- Primary completion20 Feb 2021 (estimated)
- Study completion19 Aug 2022 (estimated)
Why it stopped: Company business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895815
- Sponsor's protocol ID
- CR108188
- Other IDs
- CNTO2476MDG2003
- Status last verified
- Jan 2025
- First submitted
- 19 Aug 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT02895815
- Acronym / sponsor ID
- CR108188
- Conditions
- Visual Acuity, Geographic Atrophy, Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (estimated)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 19 Aug 2022 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of CNTO 2476 cells administered into the subretinal space by the suprachoroidal surgical approach and the subretinal access kit (SRAK-02) in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD).
Detailed description
This is a Phase 2 study to evaluate the efficacy and safety of a single subretinal administration of CNTO 2476 compared with the untreated control group, as well as to assess the safety and usability profile of the procedure and the device for cell therapy delivery in participants with visual acuity impairment associated with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration (AMD). The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 month, 12 months and every 6 month thereafter. Participant's safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNTO 2476 (6.0 * 10^4 cells) | Experimental | Combination Product: CNTO 2476 (6.0 * 10^4 cells)Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 microliter (mcL) given by subretinal delivery system. |
| CNTO 2476 (3.0 * 10^5 cells) | Experimental | Combination Product: CNTO 2476 (3.0 * 10^5 cells)Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system. |
| Control Group | No intervention | –Participants will undergo observations without surgery. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 28 days prior to initial randomization by the central reading center using fundus photographs and including the following; a) The study eyes must have at least 1 GA lesion that involves the fovea, and a Macular Photocoagulation Study (MPS) disc areas (DA) of >= 1 and <= 7 (1 Macular Photocoagulation Study Disc Area (MPS DA equivalent to 2.54 millimeter (mm)^2 on the retina) determined by screening images of fundus autofluorescence photographs as calculated by the reading center. If GA is multifocal, at least 1 lesion must be >= 0.5 DA, b) GA must be able to be photographed in its entirety and may be contiguous with peripapillary atrophy, c) Retinal photographs, fundus autofluorescence images, and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained d) The imaging center must be able to delineate and confirm peripapillary atrophy with fundus photography and fundus autofluorescence, e) Images must include the central field 1, 2, and 3 field images as defined by the University of Wisconsin standards as well as a supero temporal image to capture the subretinal injection area if possible
- Female participants must be postmenopausal with last menses 12 months prior, or longer without medical reasons (example, treatment with a drug), or a measured follicle stimulating hormone >= 26 milli-international units per milliliter (mIU/mL)
- Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 (Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR value 0.6-1.6). BCVA in the study eye must be worse than the BCVA in the fellow eye at screening
- Male participants must be sterile or willing to use 2 approved methods of contraception from first day postoperatively to 3 months postoperatively
Key exclusion criteria (5 listed)
- Participant has a history of neovascular ("wet") AMD in the study eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if antivascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to screening
- A diagnosis of glaucoma with an intraocular pressure (IOP) >= 25 millimeter of mercury (mm Hg) 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)
- Myopia >-8 diopters and participants with >4 diopters of astigmatism, and >+10 diopters of hyperopia
- Previous vitrectomy, retinal detachment repair, submacular surgery, other surgical interventions targeting AMD, scleral buckling or glaucoma filtration surgery or any other extraocular or orbital procedure in the study eye that, in the opinion of the surgeon, would hamper the suprachoroidal cannulation procedure in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTO 2476 (6.0 * 10^4 cells)Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit [SRAK-02 kit] and third arm accessory). | Combination product | CNTO 2476 (6.0 * 10^4 cells) |
| CNTO 2476 (3.0 * 10^5 cells)Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory). | Combination product | CNTO 2476 (3.0 * 10^5 cells) |
Primary outcome
Percentage of Participants Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at Month 6
Time frame: 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). The ETDRS chart at 4 meters is considered the 'gold standard' for visual acuity testing in clinical research for its physical and statistical properties.
20 secondary outcomes
Percentage of Participants Showing Improvement >=15 BCVA Letters From Baseline at 12 Month
Time frame: Baseline and Month 12
Percentage of Participants Losing >=15 Best Corrected Visual Acuity (BCVA) Letters From Baseline at 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Change in Mean Number of BCVA Letters From Baseline at 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Change in Growth Rate of Geographic Atrophy (GA) Lesion Documented at Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Mean Change in Reading Acuity (RA) From baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Mean Change in Maximum Reading Speed (MRS) From Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Mean Change in Critical Print Size (CPS) From Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Mean Change in Low Luminance Best Corrected Visual Acuity (LL BCVA) Letters From Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Percentage of Participants With Gain of >= 15 Letters in LL BCVA From Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Mean Change in Contrast Sensitivity From Baseline to 6 and 12 Months
Time frame: Baseline, Month 6 and 12
Number of Participants With Significant Changes in Retinal Morphology
Time frame: Baseline, Month 6 and 12
Percentage of Participants who Convert to Neovascular Age-Related Macular Degeneration (AMD) in the Study Eye and in the Fellow Eye
Time frame: Baseline, Month 6 and 12
Percentage of Participants who Achieved Technical Success in the Active Drug Group
Time frame: 6 Months
Percentage of Participants who Achieved Procedural Success in the Active Drug Group
Time frame: Month 6 and 12
Number of Participants with Ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Long term Follow up (Month 36)
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Short Form (36) Health Survey
Time frame: Baseline, Month 6 and 12
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health Related Quality of Life as Assessed by Functional Reading Index Questionnaire (FRI)
Time frame: Baseline, Month 6 and 12
Incidence of Anti-CNTO 2476 Antibodies
Time frame: Baseline, Day 7 and 15, Month 2, 3 and 6
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Score
Time frame: Baseline, Month 6 and 12
Mean Change From Baseline at 6 and 12 Months in Participants Reported Health-Related Quality of Life as Assessed by Near Vision Subscale Score
Time frame: Baseline, Month 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTO 2476 (6.0 * 10^4 cells) and CNTO 2476 (3.0 * 10^5 cells) in people with Visual Acuity and Geographic Atrophy, run by Janssen Pharmaceutical K.K..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Showing Improvement From Baseline of Greater Than or Equal to (>=) 15 Letters in Best Corrected Visual Acuity (BCVA) at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.