Trial · NCT03780972
A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
NCT03780972, Phase 1, Completed, ONL Therapeutics; results first posted 2024-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment. Trials, record NCT03780972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03780972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
- NCT number
- NCT03780972
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- ONL Therapeutics
- Conditions
- Rhegmatogenous Retinal Detachment - Macula Off
- Interventions
- ONL1204, Intravitreal Injection, Collection of ocular fluids
- First posted
- 2018-12-19
- Last updated
- 2024-09-24
- Results first posted
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Event (AE) Reporting | 24 weeks | AEs restricted to treatment-emergent AEs (TEAEs) only. Ocular and non-ocular AEs reported separately. See AE Reporting Table for descriptive ocular and non-ocular AE findings. |
| Primary | BCVA (LogMAR) at Final Study Visit | 24 weeks | BCVA was performed in the study eye using ETDRS methodology and letters read were converted to a logMAR value using the following equation: logMAR = -0.02 × ETDRS + 1.7. |
| Other | Exploratory Outcome-ONL1204 Concentration | 24 weeks | Measurement of ONL1204 in plasma (ng/ml) after drug administration. For all subjects, the concentration was \<LLOQ. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Event (AE) Reporting | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | BCVA (LogMAR) at Final Study Visit | 24 weeks | logMAR | MEAN | |
| OTHER_PRE_SPECIFIED | Exploratory Outcome-ONL1204 Concentration | 24 weeks | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Event (AE) Reporting | Cohort 1 Dose A | 3 | Participants | ||
| Adverse Event (AE) Reporting | Cohort 2 Dose B | 3 | Participants | ||
| Adverse Event (AE) Reporting | Cohort 3 Dose C | 3 | Participants | ||
| Adverse Event (AE) Reporting | Cohort 4 Dose D | 2 | Participants | ||
| BCVA (LogMAR) at Final Study Visit | Cohort 1 Dose A | 0.52 | Full Range 0.2 to 0.7 | logMAR | |
| BCVA (LogMAR) at Final Study Visit | Cohort 2 Dose B | 0.50 | Full Range 0.2 to 0.8 | logMAR | |
| BCVA (LogMAR) at Final Study Visit | Cohort 3 Dose C | 0.77 | Full Range 0.5 to 1.3 | logMAR | |
| BCVA (LogMAR) at Final Study Visit | Cohort 4 Dose D | 0.46 | Full Range 0.2 to 0.7 | logMAR | |
| Exploratory Outcome-ONL1204 Concentration | Cohort 1 Dose A | NA | Standard Deviation NA | ng/ml | |
| Exploratory Outcome-ONL1204 Concentration | Cohort 2 Dose B | NA | Standard Deviation NA | ng/ml |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Dose A | 4 | |
| Overall Study | STARTED | Cohort 2 Dose B | 4 | |
| Overall Study | STARTED | Cohort 3 Dose C | 4 | |
| Overall Study | STARTED | Cohort 4 Dose D | 2 | |
| Overall Study | COMPLETED | Cohort 1 Dose A | 4 | |
| Overall Study | COMPLETED | Cohort 2 Dose B | 4 | |
| Overall Study | COMPLETED | Cohort 3 Dose C | 4 | |
| Overall Study | COMPLETED | Cohort 4 Dose D | 2 | |
| Overall Study | NOT COMPLETED | Cohort 1 Dose A | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 Dose B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract or Worsening of Cataract | Eye disorders | Cohort 1 Dose A | 0 | 4 | |
| other | Cataract or Worsening of Cataract | Eye disorders | Cohort 2 Dose B | 1 | 4 | |
| other | Cataract or Worsening of Cataract | Eye disorders | Cohort 3 Dose C | 2 | 4 | |
| other | Cataract or Worsening of Cataract | Eye disorders | Cohort 4 Dose D | 0 | 2 | |
| other | Ocular pain post intravitreal injection/injury | Eye disorders | Cohort 1 Dose A | 1 | 4 | |
| other | Ocular pain post intravitreal injection/injury | Eye disorders | Cohort 2 Dose B | 0 | 4 | |
| other | Ocular pain post intravitreal injection/injury | Eye disorders | Cohort 3 Dose C | 0 | 4 | |
| other | Ocular pain post intravitreal injection/injury | Eye disorders | Cohort 4 Dose D | 0 | 2 | |
| other | Elevated Intraocular Pressure | Eye disorders | Cohort 1 Dose A | 1 | 4 | |
| other | Elevated Intraocular Pressure | Eye disorders | Cohort 2 Dose B | 1 | 4 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Dose A | 0 | 4 |
| Total, all-cause mortality | Cohort 2 Dose B | 0 | 4 |
| Total, all-cause mortality | Cohort 3 Dose C | 0 | 4 |
| Total, all-cause mortality | Cohort 4 Dose D | 0 | 2 |
| Total, other adverse events | Cohort 1 Dose A | 3 | 4 |
| Total, other adverse events | Cohort 2 Dose B | 3 | 4 |
| Total, other adverse events | Cohort 3 Dose C | 3 | 4 |
| Total, other adverse events | Cohort 4 Dose D | 2 | 2 |
| Total, serious adverse events | Cohort 1 Dose A | 0 | 4 |
| Total, serious adverse events | Cohort 2 Dose B | 2 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03780972
GET https://conductscience.org/api/trials/v1/NCT03780972/events?page=2