This is a pilot study to measure levels of albumin and inflammatory cytokines \[including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)\] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adrenocorticotropic hormone (ACTH) analog. The study will be conducted at the Wilmer Eye Institute, Johns Hopkins Hospital. A total of 15 patients will be enrolled and randomized 2:1 to H.P. Acthar® or standard of care. Treatment duration will be 8 weeks and study duration will be 12 weeks. There will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12). Subjects will self-administer subcutaneous injections of 80 units of H.P. Acthar® starting on post-operative day 1 for twice a week until week 8. Subjects in the control arm will be managed per the standard of care. Aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. Aqueous levels of albumin and inflammatory cytokines (including TGF-β and IL-1β) will be measured at each time point.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
11
Adrenocorticotropic hormone (ACTH) is a melanocortin peptide hormone that is normally produced in the pituitary gland and acts as a major regulator of adrenal cortex function. It stimulates the adrenal cortex to produce and secrete glucocorticoids. ACTH is available for clinical usage as an injectable gel (H.P. Acthar®).
Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States
Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 8 weeks after surgery
Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 8 weeks after surgery
Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 8 weeks after surgery
Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 1 week after surgery
Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 1 week after surgery
Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
Time frame: Baseline, 1 day after surgery, 1 week after surgery
Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
Aqueous cell is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+, with 0 meaning no aqueous cell and 4+ meaning severe aqueous cell
Time frame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
Flare is a clinical indicator of blood-retinal barrier breakdown and intraocular inflammation. It is assessed on slit-lamp examination and is graded on a scale from 0 to 4+ with 0 meaning no flare and 4+ means severe flare
Time frame: 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Change in best-corrected visual acuity as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) score in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls
The ETDRS score is a standardized score to assess visual acuity used in clinical research. The score ranges from 0 to 100, with higher scores corresponding to better visual acuity (a score of 100 corresponding to a Snellen visual acuity of 20/10).
Time frame: Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery
Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment
Recurrent retinal detachment is a common complication of PVR. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.
Time frame: 12 weeks after surgery
Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema
Macular edema is a common complication of intraocular surgery. It will be diagnosed based on clinical exam and supporting information from diagnostic tests such as Optical Coherence Tomography.
Time frame: 12 weeks after surgery
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