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- || JNJ-1887 / J&J
P1 data, Journal, Gene therapy: Phase 1 Study of JNJ-81201887 Gene Therapy in Geographic Atrophy Secondary to Age-related Macular Degeneration. (Pubmed Central) - Nov 21, 2024
All 3 studied doses of JNJ-1887 showed a manageable safety profile through 24 months of follow-up. Further investigation of JNJ-1887 for the treatment of GA is warranted.
- || JNJ-1887 / J&J
Trial completion date: A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Oct 23, 2024
P2, N=311, Recruiting, Sponsor: Janssen Research & Development, LLC
Further investigation of JNJ-1887 for the treatment of GA is warranted. Trial completion date: Aug 2029 --> Dec 2029
- ||| JNJ-1887 / J&J
Enrollment closed: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Oct 23, 2024
P2, N=305, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Aug 2029 --> Dec 2029 Recruiting --> Active, not recruiting
- ||||| JNJ-1887 / J&J
New P2 trial: A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Oct 9, 2024
P2, N=311, Recruiting, Sponsor: Janssen Research & Development, LLC
- || JNJ-1887 / J&J
Trial completion date: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Apr 24, 2024
P2, N=300, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Trial completion date: Jun 2026 --> Jan 2026
- || JNJ-1887 / J&J
Trial completion date: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jan 3, 2024
P2, N=300, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jun 2026 --> Jan 2026 Trial completion date: Jan 2026 --> Jun 2026
- | JNJ-1887 / J&J
Phase classification: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Dec 6, 2023
P2, N=300, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jan 2026 --> Jun 2026 Phase classification: P2b --> P2
- |||||| JNJ-1887 / J&J
New P2b trial: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Apr 13, 2023
P2b, N=300, Recruiting, Sponsor: Janssen Research & Development, LLC
- JNJ-1887 / J&J
Phase 1 Study of JNJ-81201887 Gene Therapy in Geographic Atrophy (GA) Due to Age-related Macular Degeneration (AMD) (Fontainebleau - Miami, FL) - Jan 13, 2023 - Abstract #Macula2023Macula_179;
At 24 months, all 3 doses of JNJ-1887 were tolerated with a manageable safety profile. Further investigation of JNJ-1887 for the treatment of GA secondary to dry AMD is warranted.
- || Review, Journal: Gene targeting as a therapeutic avenue in diseases mediated by the complement alternative pathway. (Pubmed Central) - Nov 15, 2022
This review explains key concepts of RNA and DNA targeting and discusses assets in clinical development for the treatment of diseases driven by the alternative pathway, including the RNA-targeting therapeutics ALN-CC5, ARO-C3, and IONIS-FB-LRX, and the gene therapies GT005 and HMR59. These therapies are but the spearhead of potential drug candidates that might revolutionize the field in coming years.
- || JNJ-1887 / J&J
Trial completion: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - May 25, 2022
P1, N=25, Completed, Sponsor: Janssen Research & Development, LLC
These therapies are but the spearhead of potential drug candidates that might revolutionize the field in coming years. Active, not recruiting --> Completed
- || Review, Journal: Review of gene therapies for age-related macular degeneration. (Pubmed Central) - Apr 19, 2022
Retinal gene therapies offer the potential for life-changing treatment for chronic conditions like age-related macular degeneration with a single administration. In doing so, gene therapies change the landscape of treatment options for these chronic conditions for both patient and provider.
- | JNJ-81201887 / J&J
Enrollment change, Trial withdrawal, Metastases: Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA) (clinicaltrials.gov) - May 9, 2021
P2, N=0, Withdrawn, Sponsor: Hemera Biosciences
In doing so, gene therapies change the landscape of treatment options for these chronic conditions for both patient and provider. N=132 --> 0 | Not yet recruiting --> Withdrawn
- || JNJ-81201887 / J&J
Trial initiation date, Metastases: Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA) (clinicaltrials.gov) - Feb 10, 2021
P2, N=132, Not yet recruiting, Sponsor: Hemera Biosciences
N=132 --> 0 | Not yet recruiting --> Withdrawn Initiation date: Jul 2020 --> Jul 2021
- | JNJ-1887 / J&J
Trial completion date: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Sep 7, 2020
P1, N=25, Active, not recruiting, Sponsor: Hemera Biosciences
Initiation date: Jul 2020 --> Jul 2021 Trial completion date: Feb 2021 --> Jan 2022
- |||| JNJ-81201887 / J&J
New P2 trial, Metastases: Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA) (clinicaltrials.gov) - Apr 23, 2020
P2, N=132, Not yet recruiting, Sponsor: Hemera Biosciences
- | Soliris (eculizumab) / Alexion Pharma
Journal: Complement inhibition as a therapeutic strategy in retinal disorders. (Pubmed Central) - Apr 22, 2020
LFG316 (C5 inhibitor) and CLG561 (properdin inhibitor) failed to halt GA progression in phase 2 studies...Complement inhibition by gene therapy will be explored in the phase 1 trial of HMR59 in AMD patients. Expert opinion: While complement inhibition has not yet demonstrated ability to halt GA progression in a phase 3 trial, further study is warranted.
- || JNJ-1887 / J&J
Enrollment closed: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Jan 31, 2020
P1, N=25, Active, not recruiting, Sponsor: Hemera Biosciences
Expert opinion: While complement inhibition has not yet demonstrated ability to halt GA progression in a phase 3 trial, further study is warranted. Recruiting --> Active, not recruiting
- || JNJ-81201887 / J&J
Trial completion, Metastases: Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59 (clinicaltrials.gov) - Dec 11, 2019
P1, N=17, Completed, Sponsor: Hemera Biosciences
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | JNJ-1887 / J&J
Trial completion date: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Dec 4, 2019
P1, N=25, Recruiting, Sponsor: Hemera Biosciences
Active, not recruiting --> Completed Trial completion date: Feb 2020 --> Feb 2021
- || JNJ-1887 / J&J
Enrollment change: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Jan 8, 2019
P1, N=25, Recruiting, Sponsor: Hemera Biosciences
Trial completion date: Feb 2020 --> Feb 2021 N=10 --> 25
- | JNJ-1887 / J&J
Enrollment open: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Sep 14, 2018
P1, N=10, Recruiting, Sponsor: Hemera Biosciences
N=10 --> 25 Not yet recruiting --> Recruiting
- | JNJ-1887 / J&J
New P1 trial: AAVCAGsCD59 for the Treatment of Wet AMD (clinicaltrials.gov) - Jul 12, 2018
P1, N=10, Not yet recruiting, Sponsor: Hemera Biosciences
- | JNJ-81201887 / J&J
Enrollment closed, Enrollment change, Metastases: Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59 (clinicaltrials.gov) - Dec 20, 2017
P1, N=17, Active, not recruiting, Sponsor: Hemera Biosciences
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=25 --> 17
- | JNJ-81201887 / J&J
New P1 trial, Metastases: Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59 (clinicaltrials.gov) - May 9, 2017
P1, N=25, Recruiting, Sponsor: Hemera Biosciences