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Article ; Online: Travel to high mountain elevations following vitrectomy with intraocular gas.

Levasseur, Steve D / Rahhal, Firas M

2013 Volume 33, Issue 7, Page(s) 1456–1461

Abstract: Purpose: To evaluate the effects and safety of travel by land through high mountainous elevations after surgery in patients who have undergone pars plana vitrectomy with intraocular gas.: Methods: A retrospective cohort study of 75 patients post pars ...

Abstract	Purpose: To evaluate the effects and safety of travel by land through high mountainous elevations after surgery in patients who have undergone pars plana vitrectomy with intraocular gas. Methods: A retrospective cohort study of 75 patients post pars plana vitrectomy with intraocular gas who traveled by land through mountain elevations of up to 3895 feet above sea level within 1 day of surgery. Results: The average rate of ascent through the mountains was 29 ft/min and the maximum theoretical ocular compensation was 0.57 cubic centimeters (cc), which occurred at 4259 feet above sea level. A statistically significant change in postoperative intraocular pressure was found when compared with preoperative (P = 0.010), with two factors influencing this change: the type of gas (C3F8, P = 0.038) and lens status (pseudophakic, P = 0.010), with a mean final intraocular pressure still within the safe range. There were no cases of retinal vascular occlusion, acute elevations of intraocular pressure requiring surgical intervention, or symptomatic visual field loss attributable to elevated intraocular pressure. Conclusion: It seems that patients with a complete fill of intraocular gas after pars plana vitrectomy may travel safely by land through mountains with a peak ascent of 3895 feet, final ascent of 2787 feet, and a mean rate of 29 ft/min. These findings can significantly impact patient costs and convenience.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Altitude ; Endotamponade ; Female ; Fluorocarbons/administration & dosage ; Humans ; Intraocular Pressure/physiology ; Male ; Middle Aged ; Ocular Hypertension/etiology ; Ocular Hypertension/physiopathology ; Retrospective Studies ; Travel ; Vitrectomy/adverse effects ; Vitrectomy/methods
Chemical Substances	Fluorocarbons
Language	English
Publishing date	2013-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	603192-4
ISSN	1539-2864 ; 0275-004X
ISSN (online)	1539-2864
ISSN	0275-004X
DOI	10.1097/IAE.0b013e318280766f
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Article ; Online: Congenital optic nerve anomaly and migration of subretinal oil: case report and observations in one family.

Carle, Michelle V / Rahhal, Michael C / Rahhal, Firas M

Retinal cases & brief reports

2014 Volume 8, Issue 4, Page(s) 286–291

Abstract: Purpose: To describe a case of optic nerve (ON) anomaly and retinal detachment with extensive subretinal silicone oil after repair of retinal detachment. A three-generation family history of ON anomaly, two generations with detachment, is presented.: ... ...

Abstract	Purpose: To describe a case of optic nerve (ON) anomaly and retinal detachment with extensive subretinal silicone oil after repair of retinal detachment. A three-generation family history of ON anomaly, two generations with detachment, is presented. Methods: Retrospective chart review. A multigenerational family with ON anomalies and macular detachment. Results: Final repair of retinal detachment was achieved using retinotomy for removal of subretinal 5,000-centistoke silicone oil, gas-fluid exchange, and peripapillary photocoagulation. Silicone oil had been previously used successfully in this eye, yet on subsequent use resulted in subretinal migration. A four patient-three-generation family history of ON anomalies was elicited, and three members were photographed for documentation. Conclusion: Optic nerve anomalies and macular detachment present a treatment dilemma because they are associated with poor vision and often a suboptimal visual outcome after surgery. This case demonstrates a large amount of subretinal silicone oil, which migrated over a 2-month period. This case series is a report of a three-generational family demonstrating variable expressivity of ON anomalies complicated by macular detachment in two generations.
MeSH term(s)	Adolescent ; Female ; Humans ; Optic Nerve/abnormalities ; Optic Nerve Diseases/complications ; Pedigree ; Retinal Detachment/surgery ; Silicone Oils/adverse effects ; Vitrectomy/adverse effects
Chemical Substances	Silicone Oils
Language	English
Publishing date	2014
Publishing country	United States
Document type	Case Reports ; Journal Article
ISSN	1937-1578
ISSN (online)	1937-1578
DOI	10.1097/ICB.0000000000000076
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Article ; Online: Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy.

Humayun, Mark S / Clegg, Dennis O / Dayan, Margot S / Kashani, Amir H / Rahhal, Firas M / Avery, Robert L / Salehi-Had, Hani / Chen, Sanford / Chan, Clement / Palejwala, Neal / Ingram, April / Mitra, Debbie / Pennington, Britney O / Hinman, Cassidy / Faynus, Mohamed A / Bailey, Jeffrey K / Johnson, Lincoln V / Lebkowski, Jane S

Ophthalmology

2023

Abstract: Purpose: To report long-term results from a phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in patients with advanced geographic atrophy (GA).: Design: A single-arm, ...

Abstract	Purpose: To report long-term results from a phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in patients with advanced geographic atrophy (GA). Design: A single-arm, open-label phase 1/2a clinical trial approved by the United States Food and Drug Administration. Participants: Patients were 69-85 years of age at the time of enrollment and were legally blind in the treated eye (best-corrected visual acuity [BCVA], ≤ 20/200) as a result of GA involving the fovea. Methods: The clinical trial enrolled 16 patients, 15 of whom underwent implantation successfully. The implant was administered to the worse-seeing eye with the use of a custom subretinal insertion device. The companion nonimplanted eye served as the control. The primary endpoint was at 1 year; thereafter, patients were followed up at least yearly. Main outcome measures: Safety was the primary endpoint of the study. The occurrence and frequency of adverse events (AEs) were determined by scheduled eye examinations, including measurement of BCVA and intraocular pressure and multimodal imaging. Serum antibody titers were collected to monitor systemic humoral immune responses to the implanted cells. Results: At a median follow-up of 3 years, fundus photography revealed no migration of the implant. No unanticipated, severe, implant-related AEs occurred, and the most common anticipated severe AE (severe retinal hemorrhage) was eliminated in the second cohort (9 patients) through improved intraoperative hemostasis. Nonsevere, transient retinal hemorrhages were noted either during or after surgery in all patients as anticipated for a subretinal surgical procedure. Throughout the median 3-year follow-up, results show that implanted eyes were more likely to improve by > 5 letters of BCVA and were less likely to worsen by > 5 letters compared with nonimplanted eyes. Conclusions: This report details the long-term follow-up of patients with GA to receive a scaffold-based stem cell-derived bioengineered RPE implant. Results show that the implant, at a median 3-year follow-up, is safe and well tolerated in patients with advanced dry age-related macular degeneration. The safety profile, along with the early indication of efficacy, warrants further clinical evaluation of this novel approach for the treatment of GA. Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Language	English
Publishing date	2023-12-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	392083-5
ISSN	1549-4713 ; 0161-6420
ISSN (online)	1549-4713
ISSN	0161-6420
DOI	10.1016/j.ophtha.2023.12.028
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Article ; Online: Survival of an HLA-mismatched, bioengineered RPE implant in dry age-related macular degeneration.

Stem cell reports

2022 Volume 17, Issue 3, Page(s) 448–458

Abstract: Cell-based therapies face challenges, including poor cell survival, immune rejection, and integration into pathologic tissue. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy of a subretinal implant ... ...

Abstract	Cell-based therapies face challenges, including poor cell survival, immune rejection, and integration into pathologic tissue. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy of a subretinal implant consisting of a polarized monolayer of allogeneic human embryonic stem cell-derived retinal pigmented epithelium (RPE) cells in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration. Postmortem histology from one subject with very advanced disease shows the presence of donor RPE cells 2 years after implantation by immunoreactivity for RPE65 and donor-specific human leukocyte antigen (HLA) class I molecules. Markers of RPE cell polarity and phagocytosis suggest donor RPE function. Further histologic examination demonstrated CD34
MeSH term(s)	Geographic Atrophy/therapy ; Human Embryonic Stem Cells/pathology ; Humans ; Macular Degeneration/pathology ; Macular Degeneration/therapy ; Prostheses and Implants/adverse effects ; Retinal Pigment Epithelium/pathology
Language	English
Publishing date	2022-02-03
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2720528-9
ISSN	2213-6711 ; 2213-6711
ISSN (online)	2213-6711
ISSN	2213-6711
DOI	10.1016/j.stemcr.2022.01.001
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Article: Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema.

Nguyen, Quan Dong / Sepah, Yasir J / Berger, Brian / Brown, David / Do, Diana V / Garcia-Hernandez, Alberto / Patel, Sunil / Rahhal, Firas M / Shildkrot, Yevgeniy / Renfurm, Ronny W

International journal of retina and vitreous

2019 Volume 5, Page(s) 28

Abstract: Background: ASP8232 is a potent and specific small molecule vascular adhesion protein-1 (VAP-1) inhibitor. This study evaluated the effect of ASP8232 on excess retinal thickness when given alone or in combination with ranibizumab in patients with center- ...

Abstract	Background: ASP8232 is a potent and specific small molecule vascular adhesion protein-1 (VAP-1) inhibitor. This study evaluated the effect of ASP8232 on excess retinal thickness when given alone or in combination with ranibizumab in patients with center-involved diabetic macular edema (CI-DME). Methods: This was a phase 2a, placebo and sham-injection controlled, double-masked, randomized, parallel-group clinical trial. Participants were patients with CI-DME and central subfield thickness (CST) ≥ 375 µm in the study eye as assessed by spectral domain optical coherence tomography. Eligible patients were randomized to (1) daily oral ASP8232 40 mg monotherapy; (2) combination therapy of daily oral ASP8232 40 mg and monthly intravitreal ranibizumab 0.3 mg; or (3) monthly intravitreal ranibizumab 0.3 mg monotherapy. The treatment period was 12 weeks. CST and best corrected visual acuity (BCVA) were assessed at baseline and at Weeks 2, 4, 8, 12, 16 and 24. The primary outcome was the mean percent change from baseline in excess CST at Week 12. Secondary outcomes were BCVA, safety and tolerability, and pharmacokinetic and pharmacodynamic characteristics of ASP8232. Results: After 12 weeks, the mean (95% confidence interval) percent change in excess CST was 11.4% (- 15.0%, 37.8%) in the ASP8232 group, - 61.7% (- 86.1%, - 37.2%) in the ASP8232/ranibizumab group, and - 75.3% (- 94.8%, - 55.8%) in the ranibizumab group. The change from baseline in the two ranibizumab arms was statistically significant ( Conclusions: Near complete inhibition of plasma VAP-1 activity with ASP8232 had no effect on CST in patients with CI-DME. Furthermore, combination therapy did not provide additional benefit to treatment with ranibizumab alone, which significantly reduced CST and improved BCVA.
Language	English
Publishing date	2019-08-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2836254-8
ISSN	2056-9920
ISSN	2056-9920
DOI	10.1186/s40942-019-0178-7
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Article ; Online: One-Year Follow-Up in a Phase 1/2a Clinical Trial of an Allogeneic RPE Cell Bioengineered Implant for Advanced Dry Age-Related Macular Degeneration.

Translational vision science & technology

2021 Volume 10, Issue 10, Page(s) 13

Abstract: Purpose: To report 1-year follow-up of a phase 1/2a clinical trial testing a composite subretinal implant having polarized human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells on an ultrathin parylene substrate in subjects ... ...

Abstract	Purpose: To report 1-year follow-up of a phase 1/2a clinical trial testing a composite subretinal implant having polarized human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells on an ultrathin parylene substrate in subjects with advanced non-neovascular age-related macular degeneration (NNAMD). Methods: The phase 1/2a clinical trial included 16 subjects in two cohorts. The main endpoint was safety assessed at 365 days using ophthalmic and systemic exams. Pseudophakic subjects with geographic atrophy (GA) and severe vision loss were eligible. Low-dose tacrolimus immunosuppression was utilized for 68 days in the peri-implantation period. The implant was delivered to the worst seeing eye with a custom subretinal insertion device in an outpatient setting. A data safety monitoring committee reviewed all results. Results: The treated eyes of all subjects were legally blind with a baseline best-corrected visual acuity (BCVA) of ≤ 20/200. There were no unexpected serious adverse events. Four subjects in cohort 1 had serious ocular adverse events, including retinal hemorrhage, edema, focal retinal detachment, or RPE detachment, which was mitigated in cohort 2 using improved hemostasis during surgery. Although this study was not powered to assess efficacy, treated eyes from four subjects showed an increased BCVA of >5 letters (6-13 letters). A larger proportion of treated eyes experienced a >5-letter gain when compared with the untreated eye (27% vs. 7%; P = not significant) and a larger proportion of nonimplanted eyes demonstrated a >5-letter loss (47% vs. 33%; P = not significant). Conclusions: Outpatient delivery of the implant can be performed routinely. At 1 year, the implant is safe and well tolerated in subjects with advanced dry AMD. Translational relevance: This work describes the first clinical trial, to our knowledge, of a novel implant for advanced dry AMD.
MeSH term(s)	Follow-Up Studies ; Geographic Atrophy/therapy ; Hematopoietic Stem Cell Transplantation ; Humans ; Macular Degeneration/therapy ; Visual Acuity
Language	English
Publishing date	2021-10-06
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2674602-5
ISSN	2164-2591 ; 2164-2591
ISSN (online)	2164-2591
ISSN	2164-2591
DOI	10.1167/tvst.10.10.13
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Article ; Online: A bioengineered retinal pigment epithelial monolayer for advanced, dry age-related macular degeneration.

Kashani, Amir H / Lebkowski, Jane S / Rahhal, Firas M / Avery, Robert L / Salehi-Had, Hani / Dang, Wei / Lin, Chih-Min / Mitra, Debbie / Zhu, Danhong / Thomas, Biju B / Hikita, Sherry T / Pennington, Britney O / Johnson, Lincoln V / Clegg, Dennis O / Hinton, David R / Humayun, Mark S

Science translational medicine

2018 Volume 10, Issue 435

Abstract: Retinal pigment epithelium (RPE) dysfunction and loss are a hallmark of non-neovascular age-related macular degeneration (NNAMD). Without the RPE, a majority of overlying photoreceptors ultimately degenerate, leading to severe, progressive vision loss. ... ...

Abstract	Retinal pigment epithelium (RPE) dysfunction and loss are a hallmark of non-neovascular age-related macular degeneration (NNAMD). Without the RPE, a majority of overlying photoreceptors ultimately degenerate, leading to severe, progressive vision loss. Clinical and histological studies suggest that RPE replacement strategies may delay disease progression or restore vision. A prospective, interventional, U.S. Food and Drug Administration-cleared, phase 1/2a study is being conducted to assess the safety and efficacy of a composite subretinal implant in subjects with advanced NNAMD. The composite implant, termed the California Project to Cure Blindness-Retinal Pigment Epithelium 1 (CPCB-RPE1), consists of a polarized monolayer of human embryonic stem cell-derived RPE (hESC-RPE) on an ultrathin, synthetic parylene substrate designed to mimic Bruch's membrane. We report an interim analysis of the phase 1 cohort consisting of five subjects. Four of five subjects enrolled in the study successfully received the composite implant. In all implanted subjects, optical coherence tomography imaging showed changes consistent with hESC-RPE and host photoreceptor integration. None of the implanted eyes showed progression of vision loss, one eye improved by 17 letters and two eyes demonstrated improved fixation. The concurrent structural and functional findings suggest that CPCB-RPE1 may improve visual function, at least in the short term, in some patients with severe vision loss from advanced NNAMD.
MeSH term(s)	Cells, Cultured ; Female ; Geographic Atrophy/therapy ; Human Embryonic Stem Cells/cytology ; Human Embryonic Stem Cells/physiology ; Humans ; Macular Degeneration/therapy ; Male ; Prospective Studies ; Retinal Pigment Epithelium/cytology ; Stem Cell Transplantation ; Tomography, Optical Coherence
Language	English
Publishing date	2018-04-03
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.aao4097
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Article ; Online: Travel to high mountain elevations following vitrectomy with intraocular gas.

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Article ; Online: Congenital optic nerve anomaly and migration of subretinal oil: case report and observations in one family.

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Article ; Online: Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy.

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Article ; Online: Survival of an HLA-mismatched, bioengineered RPE implant in dry age-related macular degeneration.

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Article: Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema.

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Article ; Online: One-Year Follow-Up in a Phase 1/2a Clinical Trial of an Allogeneic RPE Cell Bioengineered Implant for Advanced Dry Age-Related Macular Degeneration.

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Article ; Online: A bioengineered retinal pigment epithelial monolayer for advanced, dry age-related macular degeneration.

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