Trial · NCT04757636
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
NCT04757636, Phase 3, Terminated, Opthea Limited; results first posted 2025-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD). Trials, record NCT04757636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04757636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
- NCT number
- NCT04757636
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 998 participants, actual
- Lead sponsor
- Opthea Limited
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- 2.0 mg OPT-302, 2.0 aflibercept, Sham
- First posted
- 2021-02-17
- Last updated
- 2025-08-05
- Results first posted
- 2025-08-05
- 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 beyond the primary endpoint of Week 52 (safety analysis set) were not held to the expected standards for data verification and cleaning and are reported to the best of 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 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 2.0 mg aflibercept, 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 | Proportion of 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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population. |
| Secondary | Proportion of Participants Gaining 10 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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population. |
| 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 2.0 mg aflibercept, 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. The secondary analysis presented used mixed model for repeated measures in the overall population. |
| Secondary | Proportion of 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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population. |
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 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 | Proportion of 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 | Proportion of Participants Gaining 10 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 | 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 | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of 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 Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 13.48 | Standard Error 0.729 | Letters read | |
| Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 12.82 | Standard Error 0.728 | Letters read | |
| Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters | 2.0 mg Aflibercept With Sham | 13.66 | Standard Error 0.728 | Letters read | |
| Proportion of Participants Gaining 15 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 167 | Participants | ||
| Proportion of Participants Gaining 15 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 156 | Participants | ||
| Proportion of Participants Gaining 15 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Sham | 162 | Participants | ||
| Proportion of Participants Gaining 10 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 204 | Participants | ||
| Proportion of Participants Gaining 10 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 197 | Participants | ||
| Proportion of Participants Gaining 10 or More ETDRS BCVA Letters | 2.0 mg Aflibercept With Sham | 204 | Participants | ||
| Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA) | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | -4.91 | Standard Error 0.165 | mm^2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 333 | |
| Overall Study | STARTED | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 330 | |
| Overall Study | STARTED | 2.0 mg Aflibercept With Sham | 335 | |
| Overall Study | Treated | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 333 | |
| Overall Study | Treated | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 330 | |
| Overall Study | Treated | 2.0 mg Aflibercept With Sham | 333 | |
| Overall Study | Completed Week 52 Visit | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 300 | |
| Overall Study | Completed Week 52 Visit | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 305 | |
| Overall Study | Completed Week 52 Visit | 2.0 mg Aflibercept With Sham | 308 | |
| Overall Study | COMPLETED | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 172 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events567
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 | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 83 | 333 | 87 |
| other | Cataract | Eye disorders | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 62 | 330 | 67 |
| other | Cataract | Eye disorders | 2.0 mg Aflibercept With Sham | 47 | 330 | 48 |
| other | Vitreous detachment | Eye disorders | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 18 | 333 | 18 |
| other | Vitreous detachment | Eye disorders | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 9 | 330 | 9 |
| other | Vitreous detachment | Eye disorders | 2.0 mg Aflibercept With Sham | 6 | 330 | 7 |
| other | Conjunctival haemorrhage | Eye disorders | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 17 | 333 | 20 |
| other | Conjunctival haemorrhage | Eye disorders | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 24 | 330 | 30 |
| other | Conjunctival haemorrhage | Eye disorders | 2.0 mg Aflibercept With Sham | 13 | 330 | 15 |
| other | Visual acuity reduced | Eye disorders | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 17 | 333 | 19 |
1 to 10 of 567Source ClinicalTrials.gov
See all 567 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 9 | 333 |
| Total, all-cause mortality | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 12 | 330 |
| Total, all-cause mortality | 2.0 mg Aflibercept With Sham | 6 | 330 |
| Total, other adverse events | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 288 | 333 |
| Total, other adverse events | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 290 | 330 |
| Total, other adverse events | 2.0 mg Aflibercept With Sham | 282 | 330 |
| Total, serious adverse events | 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 71 | 333 |
| Total, serious adverse events | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 61 | 330 |
| Total, serious adverse events | 2.0 mg Aflibercept With Sham | 68 | 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/NCT04757636
GET https://conductscience.org/api/trials/v1/NCT04757636/events?page=2