PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

Retina
Baruch D KuppermannBrimo DDS Gen 1 Study Group

Abstract

To evaluate the safety and efficacy of Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant, in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Phase 2, randomized, multicenter, double-masked, 24-month study. Study eyes were treated (Day 1; Month 6 retreatment) with Brimo DDS 132 µg (n = 49), Brimo DDS 264 µg (n = 41), or sham procedure (n = 23). The primary timepoint for efficacy analysis was Month 12. Mean GA area growth at Month 12 was 1.78 mm2, 1.59 mm2, and 2.19 mm2 in the Brimo DDS 132 µg, 264 µg, and sham groups, respectively. Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than sham; between-group differences were significant (P ≤ 0.032) at Month 3. In patients with baseline lesion area ≥6 mm2 (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 and 264 µg at Month 12 (P ≤ 0.050 vs. sham). Treatment-related adverse events were usually injection procedure-related. Brimo DDS demonstrated a favorable safety profile and reduced GA lesion area growth at Month 3. Lesion growth at Month 12 was reduced in patients with baseline GA lesion area ≥6 mm2. The results support Phase...Continue Reading

References

Dec 10, 1999·Controlled Clinical Trials·UNKNOWN Age-Related Eye Disease Study Research Group
Apr 14, 2004·Archives of Ophthalmology·David S FriedmanUNKNOWN Eye Diseases Prevalence Research Group
Mar 13, 2008·British Medical Bulletin·H L CookA Tufail
Sep 16, 2009·Archives of Ophthalmology·Anne S LindbladUNKNOWN Age-Related Eye Disease Study Research Group
Jan 25, 2011·American Journal of Ophthalmology·Theodore KrupinUNKNOWN Low-Pressure Glaucoma Study Group
Jun 16, 2012·Nature Reviews. Drug Discovery·Kang ZhangRobert N Weinreb
Dec 30, 2014·Ophthalmology·Juan E GrunwaldUNKNOWN Comparison of Age-related Macular Degeneration Treatments Trials Research Group
Apr 11, 2015·American Journal of Ophthalmology·Alicja R RudnickaChristopher G Owen
Dec 2, 2015·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Claudio RamírezM Cristina Kenney
Jan 13, 2017·Ophthalmology·Juan E GrunwaldUNKNOWN Comparison of Age-Related Macular Degeneration Treatments Trials Research Group
Jul 14, 2017·Investigative Ophthalmology & Visual Science·Karl CsakyJacque L Duncan
Oct 17, 2017·The Lancet Global Health·Seth R FlaxmanUNKNOWN Vision Loss Expert Group of the Global Burden of Disease Study
Jan 29, 2019·Expert Opinion on Biological Therapy·Enoch KassaPravin U Dugel

❮ Previous
Next ❯

Citations

Jan 21, 2021·Pharmaceutics·Hyeong Min Kim, Se Joon Woo
Mar 4, 2021·International Journal of Molecular Sciences·Liang Wang, Xiaobo Mao
Mar 21, 2021·The British Journal of Ophthalmology·Thales Antonio Cabral de GuimaraesMichel Michaelides
Apr 25, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Hannah J Yu, Charles C Wykoff
May 26, 2021·Expert Opinion on Emerging Drugs·Masumi G AsahiRon P Gallemore
Nov 13, 2021·Translational Vision Science & Technology·Anthony GigonIrmela Mantel

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Gan to kagaku ryoho. Cancer & chemotherapy
Y Mizushima
Nihon rinsho. Japanese journal of clinical medicine
Y Mizushima
International Journal of Leprosy
H W WADE
International Journal of Leprosy
H W WADE
Antimicrobial Agents and Chemotherapy
J T BiggsJ H Peters
© 2021 Meta ULC. All rights reserved