Article ; Online: Oral minocycline for the treatment of retinitis pigmentosa-associated cystoid macular edema: results of a phase I/II clinical trial.
2023 Volume 261, Issue 8, Page(s) 2209–2220
Abstract: Purpose: The etiology of retinitis pigmentosa (RP)-associated cystoid macular edema (CME) has been related to retinal neuroinflammation and microglial activation. Minocycline, a drug FDA-approved for anti-microbial indications, also inhibits microglial ... ...
| Abstract | Purpose: The etiology of retinitis pigmentosa (RP)-associated cystoid macular edema (CME) has been related to retinal neuroinflammation and microglial activation. Minocycline, a drug FDA-approved for anti-microbial indications, also inhibits microglial activation and expression of inflammatory mediators. This study investigates the safety and efficacy of oral minocycline as primary treatment for RP-associated CME. Methods: A single-center, prospective, open-label phase I/II clinical trial enrolled five participants with RP-associated CME. Participants had lead-in assessments prior to the initiation of oral minocycline 100 mg twice daily for 12 months. Main outcome variables included changes in best-corrected visual acuity (BCVA) and retinal central subfield thickness (CST) measured using spectral domain optical coherence tomography relative to mean of pre-treatment measurements. Results: The study drug was well tolerated and not associated with any severe adverse events. No significant changes in mean BCVA from study baseline were noted in either the study eye (+ 0.7 ± 4.1 letters at 6 months, - 1.1 ± 1.7 letters at 12 months) or the qualifying fellow eye (- 0.3 ± 3.4 letters at 6 months, - 0.3 ± 4.6 letters at 12 months) (p > 0.05 for all comparisons). Mean percentage changes in CST from baseline however decreased progressively with treatment (decreases at 6 and 12 months: study eyes 3.9 and 9.8%; qualifying fellow eyes 1.4 and 7.7%). Considering all eyes (n = 10), mean percentage CST decrease at 6 and 12 months was 2.7 ± 9.5% (p = 0.39) and 8.7 ± 9.5% (p = 0.02) respectively. Conclusion: Oral minocycline administration over 12 months was associated with no significant changes in mean BCVA and a small but progressive decrease in mean CST. Trial registration: NCT02140164 (05/2014). |
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| MeSH term(s) | Humans ; Macular Edema/etiology ; Minocycline/therapeutic use ; Prospective Studies ; Retinitis Pigmentosa/complications ; Retina ; Tomography, Optical Coherence/methods |
| Chemical Substances | Minocycline (FYY3R43WGO) |
| Language | English |
| Publishing date | 2023-03-08 |
| Publishing country | Germany |
| Document type | Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article |
| ZDB-ID | 8435-9 |
| ISSN | 1435-702X ; 0721-832X |
| ISSN (online) | 1435-702X |
| ISSN | 0721-832X |
| DOI | 10.1007/s00417-023-05986-6 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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