PMID- 37197702
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230519
IS  - 2666-9145 (Electronic)
IS  - 2666-9145 (Linking)
VI  - 3
IP  - 3
DP  - 2023 Sep
TI  - Phase I NT-501 Ciliary Neurotrophic Factor Implant Trial for Primary Open-Angle 
      Glaucoma: Safety, Neuroprotection, and Neuroenhancement.
PG  - 100298
LID - 10.1016/j.xops.2023.100298 [doi]
LID - 100298
AB  - PURPOSE: To assess the safety and efficacy of a ciliary neurotrophic factor 
      (CNTF) intraocular implant on neuroprotection and neuroenhancement in glaucoma. 
      DESIGN: Open-label, prospective, phase I clinical trial. PARTICIPANTS: A total of 
      11 participants were diagnosed with primary open-angle glaucoma (POAG). One eye 
      of each patient was assigned as the study (implant) eye. METHODS: The study eye 
      was implanted with a high-dose CNTF-secreting NT-501 implant, whereas the other 
      eye served as a control. All patients were followed up for 18 months. Analysis 
      was limited to descriptive statistics. MAIN OUTCOME MEASURES: Primary outcome was 
      safety through 18 months after implantation assessed by serial eye examinations, 
      structural and functional testing, and adverse events (AEs) recording. Parameters 
      measured included visual acuity (VA), Humphrey visual field (HVF), pattern 
      electroretinogram, scanning laser polarimetry with variable corneal compensation 
      (GDx VCC), and OCT. These parameters were also used for secondary analysis of 
      efficacy outcome. RESULTS: All NT-501 implants were well tolerated with no 
      serious AEs associated with the implant. The majority of AEs were related to the 
      implant placement procedure and were resolved by 12 weeks after surgery. 
      Foreign-body sensation was the most commonly reported AE and was self-limited to 
      the postoperative period. The most common implant-related AE was pupil miosis; no 
      patients underwent explant. Visual acuity and contrast sensitivity decreased more 
      in fellow eyes than in study eyes (VA, -5.82 vs. -0.82 letters; and contrast 
      sensitivity, -1.82 vs. -0.37 letters, for fellow vs. study eyes, respectively). 
      The median HVF visual field index and mean deviation measurements worsened 
      (decreased) in fellow eyes (-13.0%, -3.9 dB) and improved (increased) in study 
      eyes (2.7%, 1.2 dB). Implanted eyes showed an increase in retinal nerve fiber 
      layer thickness measured by OCT and by GDx VCC (OCT, 2.66 mum vs. 10.16 mum; and 
      GDx VCC, 1.58 mum vs. 8.36 mum in fellow vs. study eyes, respectively). 
      CONCLUSIONS: The NT-501 CNTF implant was safe and well tolerated in eyes with 
      POAG. Eyes with the implant demonstrated both structural and functional 
      improvements suggesting biological activity, supporting the premise for a 
      randomized phase II clinical trial of single and dual NT-501 CNTF implants in 
      patients with POAG, which is now underway. FINANCIAL DISCLOSURES: Proprietary or 
      commercial disclosure may be found after the references.
FAU - Goldberg, Jeffrey L
AU  - Goldberg JL
AD  - Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 
      Stanford, California.
AD  - Shiley Eye Center, University of California San Diego, School of Medicine, San 
      Diego, California.
AD  - Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 
      Miami, Florida.
FAU - Beykin, Gala
AU  - Beykin G
AD  - Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 
      Stanford, California.
FAU - Satterfield, Kellie R
AU  - Satterfield KR
AD  - Shiley Eye Center, University of California San Diego, School of Medicine, San 
      Diego, California.
FAU - Nunez, Mariana
AU  - Nunez M
AD  - Spencer Center for Vision Research, Byers Eye Institute, Stanford University, 
      Stanford, California.
AD  - Shiley Eye Center, University of California San Diego, School of Medicine, San 
      Diego, California.
AD  - Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 
      Miami, Florida.
FAU - Lam, Byron L
AU  - Lam BL
AD  - Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 
      Miami, Florida.
FAU - Albini, Thomas A
AU  - Albini TA
AD  - Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 
      Miami, Florida.
LA  - eng
PT  - Journal Article
DEP - 20230311
PL  - Netherlands
TA  - Ophthalmol Sci
JT  - Ophthalmology science
JID - 9918230896206676
PMC - PMC10183667
OTO - NOTNLM
OT  - Glaucoma
OT  - Neuroenhancement
OT  - Neuroprotection
OT  - Neurotrophic factor
EDAT- 2023/05/18 01:07
MHDA- 2023/05/18 01:08
PMCR- 2023/03/11
CRDT- 2023/05/17 20:06
PHST- 2023/01/12 00:00 [received]
PHST- 2023/01/30 00:00 [accepted]
PHST- 2023/05/18 01:08 [medline]
PHST- 2023/05/18 01:07 [pubmed]
PHST- 2023/05/17 20:06 [entrez]
PHST- 2023/03/11 00:00 [pmc-release]
AID - S2666-9145(23)00030-1 [pii]
AID - 100298 [pii]
AID - 10.1016/j.xops.2023.100298 [doi]
PST - epublish
SO  - Ophthalmol Sci. 2023 Mar 11;3(3):100298. doi: 10.1016/j.xops.2023.100298. 
      eCollection 2023 Sep.