Trial · NCT03465111
A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis
NCT03465111, Phase 2, Unknown, Metropolitan Eye Research & Surgery Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis. Trials, record NCT03465111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03465111
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis
- NCT number
- NCT03465111
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Metropolitan Eye Research & Surgery Institute
- Conditions
- Scleritis
- Interventions
- ACTH (adrenocorticotropic hormone) gel
- First posted
- 2018-03-14
- Last updated
- 2023-10-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS). | At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue | The proportion of subjects demonstrating improvement (mean change from BL) by 5 points in pain, graded on an 11-point pain intensity numerical rating scale (NRS). |
| Primary | Change in degree of inflammation, based on the standardized scleritis grading scale. | At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue | The proportion of subjects demonstrating improvement (mean change from BL) in inflammation (equal to or less than +0.5), based on the standardized scleritis grading scale. |
| Secondary | Best corrected visual acuity outcome | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Mean change from Baseline (BL) in BCVA by ≥ 10 letters or 2 lines using the ETDRS method and at week 16 and week 52 after therapy or at time of rescue. |
| Secondary | Vascular leakage outcome | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Changes in degree of leakage on fluorescein angiogram (as assessed by centralized reading center) of the optic nerve and/or retinal vasculature from Baseline (BL) through week 16 and week 52. |
| Secondary | Retinal thickness outcome | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Changes in retinal thickness as demonstrated by spectral-domain optical coherence tomography (OCT), as assessed by the centralized reading center, for subjects with macular edema from Baseline (BL) through week 16 and week 52. |
| Secondary | Scleral thickness outcome | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Changes in scleral thickness as demonstrated by spectral-domain optical coherence tomography (OCT), as assessed by the centralized reading center, from Baseline (BL) through week 16 and week 52. |
| Secondary | Dosage of systemic corticosteroids outcome | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Changes in the dosage of systemic corticosteroids from Baseline (BL) through week 16 and week 52. |
| Secondary | Response to therapy with/without systemic corticosteroids | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Proportion of subjects successfully weaned off of steroids by the primary end point. |
| Secondary | Changes in steroids dosage during study | At week 16 (primary end point) and week 52 (end of follow-up) after therapy | Mean change in the dose of steroids from BL to primary end point and from BL to week 52. |
| Other | Incidence and severity of ocular adverse events (AEs) | At Baseline (BL) and monthly visits after screening | The incidence and severity of ocular adverse events (AEs), as identified by eye examination (including BCVA testing), slit lamp biomicroscopy, optical coherence tomography OCT (anterior and posterior), anterior segment photography, fundus photography (FP) and fluorescein angiography (FA). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers38
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03465111
GET https://conductscience.org/api/trials/v1/NCT03465111/papers?page=2