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Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

Primary Purpose

Proliferative Vitreoretinopathy

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Adrenocorticotropic Hormone

About this trial

This is an interventional basic science trial for Proliferative Vitreoretinopathy focused on measuring Post-operative Intraocular Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Wilmer Eye Institute, Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

H.P. Acthar ®

Controls

Arm Description

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.

Subjects will be managed per the standard of care.

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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

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

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

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

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).

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.

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.

Full Information

NCT ID

NCT03727776

First Posted

October 31, 2018

Last Updated

August 4, 2023

Sponsor

Johns Hopkins University

Collaborators

Mallinckrodt

1. Study Identification

Unique Protocol Identification Number

NCT03727776

Brief Title

Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

Official Title

Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 19, 2019 (Actual)

Primary Completion Date

July 7, 2023 (Actual)

Study Completion Date

July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Vitreoretinopathy

Keywords

Post-operative Intraocular Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H.P. Acthar ®

Arm Type

Experimental

Arm Description

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.

Arm Title

Controls

Arm Type

No Intervention

Arm Description

Subjects will be managed per the standard of care.

Intervention Type

Drug

Intervention Name(s)

Adrenocorticotropic Hormone

Other Intervention Name(s)

H.P. Acthar Gel, Repository Corticotropin Injection

Intervention Description

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®).

Primary Outcome Measure Information:

Title

Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Title

Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Title

Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Secondary Outcome Measure Information:

Title

Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Title

Change in mean aqueous levels of TGF-B in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Title

Change in mean aqueous levels of interleukin-1B (IL-1B) in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

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

Title

Change in mean grade of aqueous cell in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

Time Frame

1 week, 4 weeks, 8 weeks and 12 weeks after surgery

Title

Change in mean grade of flare in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Description

Time Frame

1 week, 4 weeks, 8 weeks and 12 weeks after surgery

Title

Description

Time Frame

Baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after surgery

Title

Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop recurrent retinal detachment

Description

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

Title

Percentage of post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls who develop macular edema

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter A Campochiaro, MD

Organizational Affiliation

Wilmer Eye Institute, Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wilmer Eye Institute, Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

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