TrialA Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Trial details
- Registry ID
- NCT03834753
- Phase
- Phase 3
OTLK
Outlook Therapeutics, Inc.
Company identity checked against sources
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5Trials in this database
6Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Included trials
Check company identity source| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)NCT03834753 | OTLK | Phase 3 | Completed | 2021-06-07Actual |
| A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)NCT03844074 | OTLK | Phase 3 | Completed | 2020-07-23Actual |
| A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal DisordersNCT04516278 | OTLK | Phase 3 | Completed | 2021-02-10Actual |
| A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal DisordersNCT05112861 | OTLK | Phase 3 | Active not recruiting | 2027-12Estimated |
| A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)NCT06190093 | OTLK | Phase 3 | Completed | 2024-11-07Actual |
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Trial details
- Registry ID
- NCT03844074
- Phase
- Phase 3
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Trial details
- Registry ID
- NCT04516278
- Phase
- Phase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Trial details
- Registry ID
- NCT05112861
- Phase
- Phase 3
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Trial details
- Registry ID
- NCT06190093
- Phase
- Phase 3
Latest recorded trial changes
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
NCT04516278 · Outlook Therapeutics, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Frequency and Incidence of Treatment-emergent Adverse Events
+ After
Measure: Number of Participants With Adverse Events
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT03834753 · Outlook Therapeutics, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA)
+ After
Measure: Proportion of Subjects Who Gain 15 or More Letters in Best Corrected Visual Acuity (BCVA)
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT06190093 · Outlook Therapeutics, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8
+ After
Measure: Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
NCT04516278 · Outlook Therapeutics, Inc.
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: Frequency and incidence of treatment-emergent adverse events
+ After
Measure: Frequency and Incidence of Treatment-emergent Adverse Events
Actual enrollment increased by 2 participants
− Before
195 participants (actual)
+ After
197 participants (actual)
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
NCT05112861 · Outlook Therapeutics, Inc.
Primary completion date changed
− Before
Mar 2025
+ After
Dec 2027