Approval Probability
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Also known as HMR59, JNJ-81201887
AAVCAGsCD59 · 3 trials · 3 indications
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.
BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.
Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye.
Measure intraocular inflammation, ocular changes and systemic side effects following a single intraocular injection of AAVCAGsCD59
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-81201887 Low Dose | EXPERIMENTAL | Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study. |
| Arm B: JNJ-81201887 High dose | EXPERIMENTAL | Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study. |
| Arm C: Sham Procedure | SHAM_COMPARATOR | Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study. |
| Low Dose | EXPERIMENTAL | AAVCAGsCD59 |
| Mid Dose | EXPERIMENTAL | AAVCAGsCD59 |
| High Dose | EXPERIMENTAL | AAVCAGsCD59 |
| Name | Type | Description |
|---|---|---|
| JNJ-81201887 | DRUG | No study intervention will be administered as part of this LTE study. |
| Sham Procedure | OTHER | No study intervention will be administered as part of this LTE study. |
| Prednisone | DRUG | Prednisone will be administered as oral capsule. |
| Placebo | OTHER | Prednisone matching placebo will be administered as oral capsule. |
| Triamcinolone | DRUG | Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice. |
| AAVCAGsCD59 | BIOLOGICAL | AAVCAGsCD59 is administered as a single intravitreal injection in an office setting |
Inclusion Criteria: * Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) * Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contracep...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
AAVCAGsCD59 is an investigational gene therapy being studied for the treatment of advanced dry age-related macular degeneration (AMD). It is administered to patients aged 50 years and older. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AAVCAGsCD59 is a gene therapy designed to deliver the CD59 gene, which encodes a protein that inhibits the complement system, a part of the immune response implicated in the progression of dry age-related macular degeneration. By expressing CD59, the therapy aims to protect retinal cells from complement-mediated damage.
AAVCAGsCD59 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical research on this gene therapy for the treatment of advanced dry age-related macular degeneration.
AAVCAGsCD59 is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 17 participants with dry age-related macular degeneration. The drug remains investigational and is not yet approved for commercial use.
AAVCAGsCD59 has one completed clinical trial registered as NCT03144999, titled 'Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59.' This Phase 1 study enrolled 17 participants in the United States and evaluated the therapy in patients with dry age-related macular degeneration.