Oral Minocycline for GA
Research type
Research Study
Full title
Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration
IRAS ID
180934
Contact name
Clare Bailey
Contact email
Sponsor organisation
National Eye Institute
Eudract number
2017-000946-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 5 days
Research summary
Research Summary:
Age-related macular degeneration (AMD) is a condition in which retinal degeneration
occurs predominantly in the macula in the context of aging and leads to impairment of
central visual acuity. AMD occurs in two general forms, one of which involves choroidal
neovascularization with subsequent formation of a disciform scar. This is often referred
to as the neovascular or “wet” form. A second form, the subject of this study, is termed
“dry”/atrophic macular degeneration or otherwise “geographic atrophy” (GA) and
involves a slow progressive atrophy of retinal pigment epithelial cells and photoreceptors
in the macula, also resulting in central vision loss. GA is estimated to affect up to one
million persons in the U.S. and there is no current treatment that can prevent its onset or
retard its progression.
While the etiology of GA is not completely understood, inflammatory processes involving
the activation of resident immune cells of the retina called microglia is likely to
contribute. Minocycline inhibits the activation of microglia which produce inflammatory
factors implicated in GA development. The objective of this study is to investigate the
safety and possible efficacy of oral minocycline in patients with GA.
Forty-five participants with unilateral or bilateral GA associated with AMD will be
enrolled.
This is a multi-center, prospective, single-arm, Phase II study to evaluate minocycline as
a potential treatment to decrease the rate of worsening of GA associated with AMD.
Participants will undergo a nine-month run-in phase prior to receiving investigational
product. During this run-in phase, participants will have a total of four pre-treatment
visits. Following the run-in phase, beginning at Month 9, participants will receive an oral
dose of 100 mg of minocycline twice daily for 36 months.Summary of Results:
The study entitled “Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration (AMD)” was sponsored by the National Eye Institute, National Institutes of Health. The Sponsor would like to thank all participants who participated in the study, which was conducted at two sites, the National Eye Institute (NEI) in the United States (US) and the Bristol Eye Hospital (BEH) in the United Kingdom (UK).Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60. It affects the macula, the central part of the retina needed for sharp, clear vision and activities such as reading, sewing and driving.
There are two types of AMD, wet and dry. In dry AMD, cells in the macula die. The advanced form of dry AMD is called geographic atrophy or GA, which results when light-sensitive cells in the macula die to an extent that causes central vision to decrease.
The purpose of this study was to evaluate whether a drug called minocycline was safe to give to people with GA and if it could help maintain vision in people with GA. While the cause of GA is not completely understood, it may be partly caused by inflammation which happens when cells of the retina called microglia are activated. The investigational product, Minocycline, is a drug that blocks the activation of microglia and might prevent inflammation and therefore might reduce GA.
Participants with GA in at least one eye underwent a nine-month run-in period before receiving the investigational drug, minocycline. During the run-in period, participants returned to the clinic at Months 3, 6, and 9 for eye assessments. Starting at Month 9, participants received 100 mg minocycline orally twice a day for three years. During the treatment phase, participants underwent imaging at regular intervals, including Fundus Autofluorescence (FAF), which is a test that involves taking digital photographs of the back of the eye without a contrast dye. Participants also had other assessments including laboratory tests, collect data on adverse events, and measure their best-corrected visual acuity (BCVA), which is the best possible vision an eye can see with corrective lenses, using an eye chart.
The main aim of the study was to see if treatment with oral minocycline reduced the rate of GA growth over 24 months of treatment (i.e., month 33 of follow-up) compared to the run-in phase. GA growth was measured using FAF. Overall, 37 participants enrolled (mean age 74.3 y, 57% female, 43% male), and 36 initiated the treatment phase. Of these, 21 (58%) completed at least 33 months, while 15 discontinued (8 by request, 6 for adverse events/illness, and 1 death). Results from the study showed that oral minocycline did not lead to a decrease in GA growth over 24 months, compared to the run-in phase.
Minocycline was not found to be a safety risk for participants, and all adverse reactions related to minocycline were expected in line with the product’s approved labeling.
More information on the study, including results, can be found at: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT02564978%253Fterm%253DNCT02564978%2526rank%253D1%2FNBTI%2FsLi2AQ%2FAQ%2F29bf2d1f-584e-4fd4-b792-908cb5d30d9f%2F1%2F8kwqqFWD1f&data=05%7C02%7Coxfordb.rec%40hra.nhs.uk%7Cb5e1f211f0854490d8e308dca6802cb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638568316641584733%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=DgtgwM72kKBBofHG8kryfSirvYaXhvYJTOVDg%2FwCq30%3D&reserved=0
REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0471
Date of REC Opinion
13 Nov 2017
REC opinion
Further Information Favourable Opinion