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Subconjunctival Palomid 529 in the treatment of neovascular age-related macular degeneration

  • Retinal Disorders
  • Published:
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Abstract

Background

Recent evidence suggests that neovascular age-related macular degeneration (AMD) may have an immune mediated component. Palomid 529, an investigational medication involving the immune Akt/mTOR pathway, is unique in dissociating both targets of rapamycin complexes TORC1 and TORC2. This small short-term pilot study assesses the safety of subconjunctival Palomid 529 in the treatment of neovascular AMD, with some limited efficacy information.

Methods

In this 12-week phase I open-label prospective pilot study, five participants with neovascular age-related macular degeneration that were refractory to intravitreal anti-vascular endothelial growth factor (VEGF) received three serial monthly subconjunctival doses of 1.9 mg Palomid 529. All participants were also offered concomitant monthly intravitreal anti-VEGF injections. Safety was monitored via adverse events recording. Additional outcome measures included visual acuity, optical coherence tomography, fluorescein angiography, indocyanine green angiography and fundus photography.

Results

The study drug was well-tolerated by all participants. There were no drug-related adverse events and no serious adverse events. A depot formed at the injection site, which persisted at the end of the study. In these anti-VEGF refractory patients, no clinically important changes in best-corrected visual acuity, fluorescein leakage pattern, choroidal neovascularization size on indocyanine green angiography, or autofluorescence pattern on fundus autofluorescence were observed compared to baseline. The fluid status, assessed with optical coherence tomography showed that central retinal thickness and macular volume remained stable in three participants, while the other two participants clinically progressed.

Conclusions

Serial subconjunctival injections of Palomid 529 were well-tolerated and resulted in depot formation. There were no concerns for any ocular or systemic toxicity during this small short-term study. Larger randomized studies are required to determine efficacy.

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Financial/proprietary disclosures

The authors have no proprietary or financial interests in this study.

Author information

Authors and Affiliations

  1. Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD, USA

    Monica Dalal, Jingsheng Tuo, Chi-Chao Chan & Robert Nussenblatt

  2. Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Building 10 Magnuson Room 10D40, 10 Center Drive, Bethesda, MD, 20892, USA

    Naima Jacobs-El, Benjamin Nicholson, Emily Chew, Frederick Ferris & Catherine Meyerle

Authors
  1. Monica Dalal
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  2. Naima Jacobs-El
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  3. Benjamin Nicholson
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  4. Jingsheng Tuo
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  5. Emily Chew
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  6. Chi-Chao Chan
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  7. Robert Nussenblatt
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  8. Frederick Ferris
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  9. Catherine Meyerle
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Corresponding author

Correspondence to Catherine Meyerle.

Additional information

Clinical trial registration number: NCT01271270 (http://www.clinicaltrials.gov)

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Dalal, M., Jacobs-El, N., Nicholson, B. et al. Subconjunctival Palomid 529 in the treatment of neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 251, 2705–2709 (2013). https://doi.org/10.1007/s00417-013-2375-7

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  • DOI: https://doi.org/10.1007/s00417-013-2375-7

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