Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients
| Registry | NCT03727776 |
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| Status | Completed |
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| Phase | Early Phase 1 |
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| Study type | Interventional; randomized, single group, masking: none, basic science |
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| Enrollment | 11 (Actual) |
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| Sponsor | Johns Hopkins University (Other); collaborators: Mallinckrodt |
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| Conditions | Proliferative Vitreoretinopathy |
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| Interventions | Adrenocorticotropic Hormone (Drug) |
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| Dates | start 2019-08-19, primary completion 2023-07-07, completion 2023-07-07, first posted 2018-11-01, last updated 2023-08-08 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Proliferative Vitreoretinopathy All trials of Adrenocorticotropic Hormone
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| H.P. Acthar ® | Experimental | Drug: Adrenocorticotropic Hormone | Subjects will self-administer subcutaneous injections of 80 units of adrenocorticotropic hormone analog starting on post-operative day 1 for twice a week until week 8. |
| Controls | No intervention | | Subjects will be managed per the standard of care. |
- Adrenocorticotropic Hormone (Drug), also known as H.P. Acthar Gel, Repository Corticotropin Injection: 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®).
+Outcome measures
Primary outcomes
- Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 8 weeks after surgery]: The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
- Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 8 weeks after surgery]: The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
- Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 8 weeks after surgery]: The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
Secondary outcomes
- Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 1 week after surgery]: The levels of albumin in the aqueous humor are indicative of blood-retinal barrier breakdown and will be measured in mg/dl
- Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 1 week after surgery]: The levels of TGF-B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
- Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [Baseline, 1 day after surgery, 1 week after surgery]: The levels of IL-1B in the aqueous humor are indicative of intraocular inflammation and will be measured in mg/dl
- Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [1 week, 4 weeks, 8 weeks and 12 weeks after surgery]: 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
- Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls [1 week, 4 weeks, 8 weeks and 12 weeks after surgery]: 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
- 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 [Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery]: 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).
- Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment [12 weeks after surgery]: 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.
- Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema [12 weeks after surgery]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Age ≥ 18 years
* Signed informed consent and authorization of use and disclosure of protected health information
* Patients undergoing surgery for retinal detachment due to PVR
Exclusion Criteria:
* Patients with poorly controlled diabetes mellitus (defined as HbA1C ≥ 8.0% on any anti-diabetic medications or insulin. If the patient is using any anti-diabetic medication/insulin, he becomes eligible if the medication is used continuously for >30 days)
* Patients with poorly controlled hypertension (defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg at rest with up to 3 anti-hypertensive medications. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more mins later. If the patient is using any anti-hypertensives, he becomes eligible if the medication is used continuously for >30 days)
* Patients with congestive heart failure
* Patients with scleroderma
* Patients with osteoporosis
* Patients with active systemic fungal infection
* Patients with active ocular herpes simplex
* Patients with prior or active bleeding peptic ulcer
* Pregnant patients or patients who wish to become pregnant during the course of the study (females of child-bearing age will be counselled to use contraception for the duration of the study)
+Locations (1)
| Facility | City | Country | Status |
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| Wilmer Eye Institute, Johns Hopkins Hospital | Baltimore, Maryland | United States | |
+Investigators