Trial · NCT04757610
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
NCT04757610, Phase 3, Terminated, Opthea Limited; results first posted 2025-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD). Trials, record NCT04757610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04757610
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
- NCT number
- NCT04757610
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 986 participants, actual
- Lead sponsor
- Opthea Limited
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- 2.0 mg OPT-302, 0.5 mg ranibizumab, Sham
- First posted
- 2021-02-17
- Last updated
- 2025-07-22
- Results first posted
- 2025-07-22
- Limitations and caveats
This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.~Due to clinical program termination, data reported were not held to the expected standards for data verification and cleaning and are reported to the best of the Sponsor's ability.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | Baseline to Week 52 | To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline) |
| Secondary | Participants Gaining 15 or More ETDRS BCVA Letters | Baseline to Week 52 | To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. |
| Secondary | Participants Gaining 10 More ETDRS BCVA Letters | Baseline to Week 52 | To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. |
| Secondary | Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA) | Baseline to Week 52 | To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52. |
| Secondary | Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT | at Week 52 | To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | Baseline to Week 52 | Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses. | Letters read | LEAST_SQUARES_MEAN |
| SECONDARY | Participants Gaining 15 or More ETDRS BCVA Letters | Baseline to Week 52 | Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Gaining 10 More ETDRS BCVA Letters | Baseline to Week 52 | Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA) | Baseline to Week 52 | Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses. | mm^2 | MEAN |
| SECONDARY | Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT | at Week 52 | Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 13.20 | Standard Error 0.728 | Letters read | |
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 12.41 | Standard Error 0.731 | Letters read | |
| Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 0.5 mg Ranibizumab With Sham | 14.30 | Standard Error 0.719 | Letters read | |
| Participants Gaining 15 or More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 159 | Participants | ||
| Participants Gaining 15 or More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 135 | Participants | ||
| Participants Gaining 15 or More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Sham | 164 | Participants | ||
| Participants Gaining 10 More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 198 | Participants | ||
| Participants Gaining 10 More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 182 | Participants | ||
| Participants Gaining 10 More ETDRS BCVA Letters | 0.5 mg Ranibizumab With Sham | 202 | Participants | ||
| Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA) | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | -3.359 | Standard Error 0.3483 | mm^2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 329 | |
| Overall Study | STARTED | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 326 | |
| Overall Study | STARTED | 0.5 mg Ranibizumab With Sham | 331 | |
| Overall Study | Treated | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 328 | |
| Overall Study | Treated | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 326 | |
| Overall Study | Treated | 0.5 mg Ranibizumab With Sham | 331 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 167 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 168 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab With Sham | 171 | |
| Overall Study | NOT COMPLETED | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 162 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events498
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 | Eye disorders | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 39 | 328 | 42 |
| other | Cataract | Eye disorders | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 33 | 327 | 35 |
| other | Cataract | Eye disorders | 0.5 mg Ranibizumab With Sham | 14 | 330 | 14 |
| other | Conjunctival haemorrhage | Eye disorders | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 32 | 328 | 49 |
| other | Conjunctival haemorrhage | Eye disorders | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 42 | 327 | 61 |
| other | Conjunctival haemorrhage | Eye disorders | 0.5 mg Ranibizumab With Sham | 24 | 330 | 39 |
| other | Eye pain | Eye disorders | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 32 | 328 | 70 |
| other | Eye pain | Eye disorders | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 19 | 327 | 38 |
| other | Eye pain | Eye disorders | 0.5 mg Ranibizumab With Sham | 20 | 330 | 29 |
| other | Vitreous floaters | Eye disorders | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 23 | 328 | 25 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 5 | 328 |
| Total, all-cause mortality | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 13 | 327 |
| Total, all-cause mortality | 0.5 mg Ranibizumab With Sham | 8 | 330 |
| Total, other adverse events | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 290 | 328 |
| Total, other adverse events | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 261 | 327 |
| Total, other adverse events | 0.5 mg Ranibizumab With Sham | 265 | 330 |
| Total, serious adverse events | 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 65 | 328 |
| Total, serious adverse events | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 60 | 327 |
| Total, serious adverse events | 0.5 mg Ranibizumab With Sham | 52 | 330 |
Source ClinicalTrials.gov
Papers0
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/NCT04757610
GET https://conductscience.org/api/trials/v1/NCT04757610/events?page=2