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Long-term Follow-up of the Systemic Immunosuppressive Therapy for Eye Diseases Cohort

Award Number: R01EY014943
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2004
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Long-term Follow-up of the Systemic Immunosuppressive Therapy for Eye Diseases Cohort - Project Summary (Abstract) Ocular inflammatory diseases are major causes of vision loss in the United States, occurring from a relatively early age. Immunosuppression is a critical therapeutic approach for severe cases. We previously collected data for 18,184 non-infectious ocular inflammation patients, which we now propose to leverage in order to evaluate the critical question of whether immunosuppression has a higher risk of death or death from cancer in the long run. We will do this by studying the survival of these patients for an additional 11 years since their exposure to immunosuppressive therapy (which will provide a median of >15 years’ follow-up for mortality risk following treatment). Some of these drugs have been explicitly identified as carcinogenic in humans based primarily on transplant data. We have not seen that effect in our research so far, but it is critical to assure patients that the treatments are sufficiently safe to use, hence we are proposing to extend this study. Since it also is important to understand which drugs are the most beneficial, we also propose to follow-up our current work indicating that Tumor Necrosis Factor Inhibitor (TNFi) drugs control inflammation better than “conventional” (and less expensive) treatment with antimetabolite drugs (such as methotrexate). We propose to study whether TNFi therapy has better visual acuity outcome and fewer ocular complications than single antimetabolite therapy; whether TNFi therapy also is more effective in obtaining treatment success than combined, two- drug conventional immunosuppression (an alternative, less costly approach); whether any of the individual TNFi agents (infliximab, adalimumab and etanercept) are preferable in terms of treatment success and; and how much cost is associated with these potential benefits of TNFi therapy. We also propose to create tools to help doctors identify which patients are at high risk of an unfavorable visual outcome, and to predict which patients will need higher (potentially more toxic) doses of specific immunosuppressants, to help identify who needs stronger treatment from the beginning. In addition, we aim to identify ophthalmic predictors of mortality, and whether immunosuppression in fact reduces the risk of mortality for such patients as is assumed. We further aim to estimate the incidence of and predictive factors for rhegmatogenous retinal detachment in uveitis cases. The existence of this largest, purpose-collected United States ocular inflammation database provides a unique opportunity to address many ocular questions of great importance, with a high probability of successful execution.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $2,236,075 )
2025	2025	MASSACHUSETTS EYE AND EAR INFIRMARY	243 CHARLES ST	BOSTON	MA	02114	SUFFOLK	USA	Vision Research	000	12	8/15/2025	COMPETING CONTINUATION	$2,236,075
														Subtotal = $2,236,075

Issue Date FY: 2019 ( Subtotal = -$8,695 )
2019	2014	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	11	9/17/2019	NON-COMPETING CONTINUATION	-$8,695
														Subtotal = -$8,695

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	11	2/4/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2014	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	11	1/15/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $616,325 )
2014	2014	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	11	8/12/2014	NON-COMPETING CONTINUATION	$616,325
														Subtotal = $616,325

Issue Date FY: 2013 ( Subtotal = $693,418 )
2013	2013	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	10	9/9/2013	NON-COMPETING CONTINUATION	$693,418
														Subtotal = $693,418

Issue Date FY: 2012 ( Subtotal = $726,910 )
2012	2012	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	9	8/6/2012	NON-COMPETING CONTINUATION	$726,910
														Subtotal = $726,910

Issue Date FY: 2011 ( Subtotal = $743,668 )
2011	2011	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	8	8/22/2011	NON-COMPETING CONTINUATION	$743,668
														Subtotal = $743,668

Issue Date FY: 2010 ( Subtotal = $829,809 )
2010	2010	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	7	8/23/2010	COMPETING CONTINUATION	$829,809
2010	2010	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	001	7	9/30/2010	COMPETING CONTINUATION	$0
														Subtotal = $829,809

Issue Date FY: 2009 ( Subtotal = $0 )
2009	2007	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	5	6/3/2009	NON-COMPETING CONTINUATION	$0
2009	2007	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	001	5	9/16/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2007 ( Subtotal = $531,213 )
2007	2007	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	5	6/6/2007	NON-COMPETING CONTINUATION	$531,213
														Subtotal = $531,213

Issue Date FY: 2006 ( Subtotal = $618,704 )
2006	2006	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Vision Research	000	4	4/28/2006	NON-COMPETING CONTINUATION	$618,704
														Subtotal = $618,704

Issue Date FY: 2005 ( Subtotal = $589,170 )
2005	2005	JOHNS HOPKINS UNIVERSITY	CHARLES & 34TH STREETS	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Vision Research	000	2	5/4/2005	NON-COMPETING CONTINUATION	$532,656
2005	2005	JOHNS HOPKINS UNIVERSITY	CHARLES & 34TH STREETS	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Vision Research	001	2	5/9/2005	SUPPLEMENT FOR EXPANSION	$56,514
														Subtotal = $589,170

Issue Date FY: 2004 ( Subtotal = $532,558 )
2004	2004	JOHNS HOPKINS UNIVERSITY	CHARLES & 34TH STREETS	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Vision Research	000	1	4/26/2004	NEW	$532,558
														Subtotal = $532,558

Grand Total All Awards = $8,109,155

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Long-term Follow-up of the Systemic Immunosuppressive Therapy for Eye Diseases Cohort

Award Number: R01EY014943

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2004

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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