A study to compare JNJ-81201887 to a sham procedure for the treatment of geographic atrophy secondary to age-related macular degeneration
| ISRCTN | ISRCTN38641780 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38641780 |
| EudraCT/CTIS number | 2022-500746-16 |
| IRAS number | 1006234 |
| Secondary identifying numbers | 81201887MDG2001, IRAS 1006234, CPMS 53494 |
- Submission date
- 04/03/2023
- Registration date
- 20/09/2023
- Last edited
- 14/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Age-related macular degeneration (AMD) is an eye disease that can lead to vision loss. It happens when aging causes damage to part of the eye that controls sharp, straight-ahead vision. Geographic atrophy (GA) is an advanced form of AMD that leads to progressive and permanent loss of vision. JNJ-81201887 is a gene therapy that increases the ability of the retina cells to make CD59 (a protein that protects the retina from damage caused by an essential part of the body's natural immune response called the complement system), which may help prevent further damage. In this study, researchers want to see if JNJ-81201887 is effective in reducing the growth of GA lesions in the treated eye.
Who can participate?
Male and female participants 60 years or older
What does the study involve?
After screening, participants will be randomly assigned to one of the three groups and will receive treatment as an injection in the study eye on Day 4 as shown below:
1. Group A: Single low dose JNJ-81201887.
2. Group B: Single high dose of JNJ-81201887
3. Group C: Single sham procedure (a similar procedure that involves a syringe with no needle) will be performed.
In addition to JNJ-81201887, participants will receive oral prednisone for 20 days from Day 1 and a single long acting periocular triamcinolone (corticosteroid injection) around the eye on Day 4 in the eye for prevention of eye inflammation in Group A and B. Participants in Group C will receive a placebo that is matched to oral prednisone for 20 days from Day 1 and a sham corticosteroid injection around the eye similar to Group A and B on Day 4.
Participants will enter a long-term extension study after completion of the treatment to monitor for safety.
During the study, tests will be performed such as blood and eye tests (use of various tools to take images of the inside of the eye). Blood samples, eye fluid, and tears will be taken at multiple timepoints to understand how the body responds to treatment. All systemic and eye-related side effects will be recorded until the study ends (up to 2 years and 11 months for all participants).
What are the possible benefits and risks of participating?
There is no established benefit to participants of this study. Based on scientific theory, receiving JNJ-81201887 may improve AMD. However, this cannot be guaranteed because JNJ-81201887 is still under investigation as a treatment and it is not known whether JNJ-81201887 will work. If participants are put into the placebo or sham comparator group, they will not receive JNJ-81201887 and will only receive a placebo or sham procedure during this study. Participants may experience some benefit from participation in the study that is not due to receiving study drug, but due to regular visits and assessments monitoring overall health. Participation may help other people with AMD in the future.
Participants may have side effects from the drugs or procedures used in this study that may be mild to severe and even life-threatening, and these can vary from person to person. The most likely, known risks associated with the study intervention or concomitant medications are intraocular inflammation, hypertension, hyperglycemia, immune suppression and subsequent infection risk, mood changes, weight gain, osteoporosis, corneal abrasion, retinal detachment and cataract formation after getting the study drug or placebo. There are other, less frequent risks. The participant information sheet and informed consent form, which will be signed by every participant agreeing to participate in the study, includes a detailed section outlining the known risks of participating in the study. Not all possible side effects and risks related to JNJ-81201887 are known at this moment. During the study, the sponsor may learn new information about JNJ-81201887. The study doctor will tell participants as soon as possible about any new information that might make them change their minds about being in the study, such as new risks. To minimize the risk associated with taking part in the study, participants are frequently reviewed for any side effects and other medical events. Participants are educated to report any such events to the study doctor who will provide appropriate medical care. Any serious side effects that are reported to the sponsor are thoroughly reviewed by a specialist drug safety team. There are no costs to participants to be in the study. The sponsor will pay for the study drug and tests that are part of the study. The participant will receive reasonable reimbursement for study-related costs (e.g., travel/parking costs).
Where is the study run from?
Janssen (Netherlands)
When is the study starting and how long is it expected to run for?
March 2023 to January 2026
Who is funding the study?
Janssen Research and Development (USA)
Who is the main contact?
p.stanga@theretinacliniclondon.com
lsmith8@its.jnj.com
Contact information
Scientific
50-100 Holmers Farm Way
High Wycombe
HP12 4DP
United Kingdom
| Phone | +44 (0)7771 381 624 |
|---|---|
| lsmith8@its.jnj.com |
Principal Investigator
140 Harley Street
London
W1G 7LB
United Kingdom
| Phone | +44 (0)20 4548 5310 |
|---|---|
| p.stanga@theretinacliniclondon.com |
Study information
| Study design | Phase IIb randomized double-masked parallel-group multicenter dose-ranging sham-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A phase IIb, randomized, double-masked, multicenter, dose-ranging, sham-controlled clinical trial to evaluate intravitreal JNJ-81201887 (AAVCAGsCD59) compared to sham procedure for the treatment of geographic atrophy secondary to age-related macular degeneration |
| Study acronym | PARASOL |
| Study hypothesis | Primary objective: To assess the change in growth of geographic atrophy (GA) lesions in the eyes treated with JNJ-81201887 compared to sham control. Secondary objectives: 1. To assess effect of JNJ-81201887 on low luminance visual acuity (LLVA). 2. To assess effect of JNJ-81201887 on visual function and retinal function. 3. To assess effect of JNJ-81201887 on best corrected visual acuity (BCVA). 4. To assess effect of JNJ-81201887 on functional reading independence and patient reported outcomes (PROs) |
| Ethics approval(s) |
Approved 07/09/2023, London – West London & GTAC Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8098, (0)207 104 8007, (0)207104 8256; westlondon.rec@hra.nhs.uk), ref: 23/LO/0166 |
| Condition | Geographic atrophy, secondary to age-related macular degeneration |
| Intervention | After the screening, participants will be randomly assigned to one of the three groups and will receive treatment as an injection in the study eye on Day 4 as shown below: 1. Group A: Single low dose JNJ-81201887. 2. Group B: Single high dose of JNJ-81201887. 3. Group C: Single sham procedure (a similar procedure that involves a syringe with no needle) will be performed. In addition to JNJ-81201887, participants will receive oral prednisone for 20 days from Day 1 and a single corticosteroid injection around the eye on Day 4 in the eye for prevention of eye inflammation in Group A and B. Participants in Group C will receive placebo-matched oral prednisone for 20 days and a sham corticosteroid injection around the eye similar to Group A and B from Day 1. Participants will enter a long-term extension study after completion of the treatment to monitor for safety. During the study, tests will be performed such as blood and eye tests (use of various tools to take images of the inside of the eye). Blood samples, eye fluid, and tears will be taken at multiple timepoints to understand how the body responds to treatment. All systemic and eye-related side effects will be recorded until the study ends (up to 2 years and 7 months). Participants will be randomised centrally via an online tool (IWRS). Investigational sites will not be provided with randomisation codes. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Pharmacodynamic, Genetic testing, biodistribution/shedding and immunogenicity |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | JNJ-81201887 (AAVCAGsCD59) |
| Primary outcome measure | Current primary outcome measure as of 27/08/2024: Change from baseline in square root of geographic atrophy (GA) lesion area in the study eye at Month 18 _____ Previous primary outcome measure: Change from baseline in square root of geographic atrophy (GA) lesion area in the study eye up to month 18 |
| Secondary outcome measures | Current secondary outcome measures as of 27/08/2024: 1. Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18 2. Change From Baseline in Reading Speed at Month 18 3. Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18 4. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18 5. Change From Baseline in Functional Reading Independence (FRI) Index at Month 18 6. Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18 _____ Previous secondary outcome measures: 1. Change From Baseline in Low Luminance Visual Acuity (LLVA) up to Month 18 2. Change From Baseline in Reading Speed up to Month 18 3. Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) up to Month 18 4. Change From Baseline in Best Corrected Visual Acuity (BCVA) up to Month 18 5. Change From Baseline in Functional Reading Independence (FRI) Index up to Month 18 6. Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Composite Score up to Month 18 |
| Overall study start date | 02/03/2023 |
| Overall study end date | 02/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 300 |
| Participant inclusion criteria | Current inclusion criteria as of 27/08/2024: 1. Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT). 2. If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5- disc area), as assessed by the CRC 3. GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC. 4. Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better. 5.Man or woman (according to their reproductive organs and functions assigned by chromosomal complement) _____ Previous inclusion criteria: 1. 60 years of age or older 2. Have non-subfoveal (defined as not involving the center point of the fovea) GA secondary to AMD with an area measuring 2.5 mm2 to 17.5 mm2 (1 and 7 disc areas respectively), determined by the CRC from screening images of FAF and SD-OCT. 3. A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin) test for the sample collected at Screening and a negative urine pregnancy test on Day 4 before receiving the study intervention. 4. Must sign an ICF (or their legally-acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in and able to complete all required assessments during the study. |
| Participant exclusion criteria | Current exclusion criteria as of 27/08/2024: 1. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye 2. Any prior thermal laser in the macular region, regardless of indication 3. History of retinal detachment (with or without repair) 4. Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis 5. Any sign of diabetic retinopathy or central serous chorioretinopathy _____ Previous exclusion criteria: 1. History of or presence of retinal disease other than GA: diabetic retinopathy, central serous chorioretinopathy, inherited retinal degeneration, toxic maculopathies (ie, hydroxychloroquine maculopathy), arterial and venous occlusive disease, macular hole that is present or has been previously repaired, or choroidal melanoma. 2. Presence of macular fibrosis or retinal epithelial tear, clinically relevant myopic degeneration, or vitreous hemorrhage a. Benign conditions of the vitreous (ie, posterior vitreous detachment) or peripheral retina (ie, paving stone degeneration, lattice degeneration, etc.) are permitted. 3. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye. 4. Any prior thermal laser in the macular region, regardless of indication. |
| Recruitment start date | 06/03/2023 |
| Recruitment end date | 13/09/2024 |
Locations
Countries of recruitment
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Denmark
- England
- Germany
- Hungary
- Italy
- Mexico
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
- Switzerland
- Türkiye
- United Kingdom
Study participating centres
London
W1G 9AX
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Bristol
BS1 2LX
United Kingdom
Manchester
M13 9WL
United Kingdom
London
EC1V 2PD
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
London
NW10 7NS
United Kingdom
Adelaide
SA 5000
Australia
Leige
4000
Belgium
Nova Scotia
-
Canada
Bern
-
Switzerland
-
Czech Republic
Giessen
-
Germany
Glostrop
-
Denmark
-
Spain
-
Hungary
Napoli
-
Italy
-
Netherlands
-
Poland
-
Portugal
-
Sweden
-
Türkiye
-
United States of America
Sponsor information
Industry
Archimedesweg 29
Leiden
2333CM
Netherlands
| Phone | +31 71 524 2166 |
|---|---|
| ClinicalTrialsEU@its.jnj.com | |
| Website | https://www.janssen.com/netherlands/ |
"ROR" |
https://ror.org/04cxegr21 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Janssen R&D, Janssen Research & Development, Janssen Research & Development, LLC, Janssen Research & Development LLC, Janssen Pharmaceutical Companies of Johnson & Johnson, Research & Development at Janssen, JRD, J&J PRD
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website 5. Submission to regulatory authorities 6. Other 7. Study results will be available via publication in scientific journals, the Clintrials.gov and ISRCTN databases & presentation at scientific meetings. Results will be made available to participants via a Plain Language Summary a year after the end of the study. The summary will describe the results regardless of study outcome in language that is understandable to the general public. It will not contain individual participant results or personal information. A copy of the Summary will be provided to the REC. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request through the Yale Open Data Access (YODA) Project site at yoda.yale.edu. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. |
Editorial Notes
14/01/2025: The study participating centre name and address was amended from The Retinal Clinic to The Retina Clinic.
12/09/2024: The recruitment end date was changed from 11/09/2024 to 13/09/2024.
27/08/2024: The following changes were made to the trial record:
1. The overall end date was changed from 15/07/2025 to 02/01/2026.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The recruitment end date was changed from 11/06/2024 to 11/09/2024.
7. The plain English summary was updated to reflect these changes.
04/10/2023: Internal review.
06/03/2023: Trial's existence confirmed by Health Research Authority (HRA) (UK).
