TerminatedNCT04757636COASTUpdated Aug 5, 2025Results posted

OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

A Phase 3 interventional study of 2.0 mg OPT-302 and 2.0 aflibercept in Neovascular Age-related Macular Degeneration, sponsored by Opthea Limited. Terminated at 209 sites in 30 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Opthea Limited · Phase 3, Interventional, and Treatment

Why this study was terminated

The primary endpoint was not achieved in the study.

Phase: Phase 3
Study type: Interventional
Enrollment: 998
Allocation: Randomized
Ages: 50 Years and older
Sex: All

Study summary

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Conditions studied

Neovascular Age-related Macular Degeneration

Browse trials for

Keywords

nAMD
wet AMD
Wet Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Retinal Degeneration

In context

Wet Macular Degeneration

93 studies on the registry are indexed under Wet Macular Degeneration; 10 are open to participants now.

This study's enrollment of 998 is above the median of 101 across 74 interventional studies indexed under Wet Macular Degeneration.

Browse Wet Macular Degeneration studies →

Lead sponsor

Opthea Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main Exclusion Criteria:

Any previous treatment for neovascular AMD.
ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
- Additional inclusion/exclusion criteria apply.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant: Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 998 participants (actual)

Study arms

Experimental
2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
Biological: 2.0 mg OPT-302 · Biological: 2.0 aflibercept
Experimental
2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
Biological: 2.0 mg OPT-302 · Biological: 2.0 aflibercept
Sham comparator
2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
Biological: 2.0 aflibercept · Procedure: Sham

Interventions

Biological2.0 mg OPT-302
intravitreal injection
Biological2.0 aflibercept
intravitreal injection
ProcedureSham
intravitreal injection

What researchers measure

Primary outcomes

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
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)
Time frame: Baseline to Week 52

Secondary outcomes

Proportion of Participants Gaining 15 or More ETDRS BCVA Letters
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.
Time frame: Baseline to Week 52
Proportion of Participants Gaining 10 or More ETDRS BCVA Letters
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.
Time frame: Baseline to Week 52
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
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.
Time frame: Baseline to Week 52
Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
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.
Time frame: at Week 52

Results

Posted Aug 5, 2025

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.

Participant flow

Participants 50 years or older with active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the study eye with an ETDRS BCVA score between 60 and 25 (inclusive) letters in the study eye.

Participant flow — Overall Study
Milestone	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Started	333	330	335
Treated	333	330	333
Completed week 52 visit	300	305	308
Completed	172	173	172
Not completed	161	157	163
Withdrew: Adverse event	25	8	11
Withdrew: Death	9	12	6
Withdrew: Lack of efficacy	2	0	0
Withdrew: Lost to follow-up	1	6	7
Withdrew: Physician decision	1	3	4
Withdrew: Withdrawal by subject	20	23	18
Withdrew: Discontinued study treatment at or prior to week 52	0	1	0
Withdrew: Study terminated by sponsor	103	104	114
Withdrew: Sponsor decision	0	0	1
Withdrew: Randomized in error	0	0	2

Outcome measures

PrimaryMean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters

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)

Time frame:: Baseline to Week 52
Reported as:: Least squares mean · Letters read

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
Letters read	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters	13.48 ± 0.729	12.82 ± 0.728	13.66 ± 0.728

Statistical analysis

2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · MMRM · p = 0.861409 · Least squares mean difference: -0.18 · 95% CI -2.20 to 1.84
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · MMRM · p = 0.416264 · Least squares mean difference: -0.84 · 95% CI -2.86 to 1.18

SecondaryProportion of Participants Gaining 15 or More ETDRS BCVA Letters

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.

Time frame:: Baseline to Week 52
Reported as:: Count of participants · Participants

Proportion of Participants Gaining 15 or More ETDRS BCVA Letters
Participants	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Proportion of Participants Gaining 15 or More ETDRS BCVA Letters	167	156	162

Statistical analysis

2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.981348 · Risk difference (rd): 0.1 · 95% CI -7.5 to 7.7The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.856000 · Risk difference (rd): -0.7 · 95% CI -8.5 to 7.0The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.

SecondaryProportion of Participants Gaining 10 or More ETDRS BCVA Letters

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.

Time frame:: Baseline to Week 52
Reported as:: Count of participants · Participants

Proportion of Participants Gaining 10 or More ETDRS BCVA Letters
Participants	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Proportion of Participants Gaining 10 or More ETDRS BCVA Letters	204	197	204

Statistical analysis

2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.655104 · Risk difference (rd): -1.7 · 95% CI -8.9 to 5.6The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.821257 · Risk difference (rd): -0.8 · 95% CI -8.2 to 6.5The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.

SecondaryChange in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)

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.

Time frame:: Baseline to Week 52
Reported as:: Least squares mean · mm^2

Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
mm^2	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)	-4.91 ± 0.165	-4.92 ± 0.166	-4.61 ± 0.166

Statistical analysis

2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · MMRM · p = 0.199828 · Least squares mean difference: -0.30 · 95% CI -0.76 to 0.16
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · MMRM · p = 0.188725 · Least squares mean difference: -0.31 · 95% CI -0.77 to 0.15

SecondaryProportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT

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.

Time frame:: at Week 52
Reported as:: Count of participants · Participants

Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
Participants	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT	30	32	29

Statistical analysis

2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.847810 · Risk difference (rd): -0.5 · 95% CI -5.6 to 4.6The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham · Mantel Haenszel · p = 0.718699 · Risk difference (rd): 0.9 · 95% CI -4.2 to 6.1The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.

Adverse events

Collected over From Baseline to Week 100. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	9/333 (2.7%)	71/333 (21.3%)	288/333 (86.5%)
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	12/330 (3.6%)	61/330 (18.5%)	290/330 (87.9%)
2.0 mg Aflibercept With Sham	6/330 (1.8%)	68/330 (20.6%)	282/330 (85.5%)

Most frequent serious events

Showing 10 of 173

Most frequent serious events
Event	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
PneumoniaInfections and infestations	7/333	4/330	7/330
Atrial fibrillationCardiac disorders	2/333	4/330	4/330
Acute myocardial infarctionCardiac disorders	4/333	1/330	1/330
CholecystitisHepatobiliary disorders	0/333	1/330	3/330
EndophthalmitisInfections and infestations	3/333	0/330	2/330
Cardiac failureCardiac disorders	3/333	2/330	2/330
SepsisInfections and infestations	3/333	2/330	1/330
Urinary tract infectionInfections and infestations	3/333	0/330	0/330
CataractEye disorders	1/333	2/330	0/330
Retinal haemorrhageEye disorders	0/333	2/330	2/330

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham
CataractEye disorders	83/333	62/330	47/330
COVID-19Infections and infestations	31/333	32/330	35/330
Intraocular pressure increasedInvestigations	32/333	31/330	11/330
HypertensionVascular disorders	12/333	12/330	31/330
Neovascular age-related macular degenerationEye disorders	29/333	27/330	30/330
NasopharyngitisInfections and infestations	22/333	23/330	29/330
Urinary tract infectionInfections and infestations	18/333	25/330	20/330
Conjunctival haemorrhageEye disorders	17/333	24/330	13/330
Back painMusculoskeletal and connective tissue disorders	24/333	14/330	19/330
HeadacheNervous system disorders	18/333	19/330	19/330

Baseline characteristics

Modified Intent-to-Treat (mITT) dataset 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. Data from 3 participants at a single site (all randomised to the Aflibercept + Sham arm) were excluded from all analyses based on study site noncompliance with potentially signficant impact to reliability of data.

Age, Categorical
Age, Categorical(Participants)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
<=18 years	0	0	0	0
Between 18 and 65 years	39	32	34	105
>=65 years	294	298	296	888

Age, Continuous
Age, Continuous(years)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
Mean	74.3 ± 7.80	74.9 ± 7.97	75.2 ± 8.28	74.8 ± 8.02

Sex: Female, Male
Sex: Female, Male(Participants)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
Female	190	183	184	557
Male	143	147	146	436

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
Hispanic or Latino	4	2	6	12
Not Hispanic or Latino	83	81	77	241
Unknown or Not Reported	246	247	247	740

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
American Indian or Alaska Native	3	9	6	18
Asian	29	25	29	83
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	0	0	1
White	288	287	281	856
More than one race	0	0	0	0
Unknown or Not Reported	12	9	14	35

Early Treatment Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) Letters
Early Treatment Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) Letters(letters read)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
Mean	52.8 ± 9.04	52.3 ± 9.63	52.4 ± 9.65	52.5 ± 9.44

Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)(mm^2)	2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302	2.0 mg Aflibercept With Sham	Total
Mean	6.16 ± 3.277	6.47 ± 3.137	6.54 ± 3.185	6.39 ± 3.199

Study locations

209 sites

COAST Investigational Site
Phoenix, Arizona 85053, United States
COAST Investigational Site
Arcadia, California 91006, United States
COAST Investigational Site
Huntington Beach, California 92647, United States
COAST Investigational Site
Redlands, California 92374, United States
COAST Investigational Site
Sacramento, California 95841, United States
COAST Investigational Site
Danbury, Connecticut 06810, United States
COAST Investigational Site
Altamonte Springs, Florida 32750, United States
COAST Investigational Site
Boynton Beach, Florida 33426, United States
COAST Investigational Site
Coral Springs, Florida 33067, United States
COAST Investigational Site
Melbourne, Florida 32901, United States
COAST Investigational Site
Orlando, Florida 32806, United States
COAST Investigational Site
Plantation, Florida 33324, United States
COAST Investigational Site
Sarasota, Florida 34239, United States
COAST Investigational Site
St. Petersburg, Florida 33711, United States
COAST Investigational Site
Stuart, Florida 34994, United States
COAST Investigational Site
Winter Haven, Florida 33880, United States
COAST Investigational Site
Marietta, Georgia 30060, United States
COAST Investigational Site
‘Aiea, Hawaii 96701, United States
COAST Investigational Site
Chicago, Illinois 60611, United States
COAST Investigational Site
Springfield, Illinois 62704, United States
COAST Investigational Site
Urbana, Illinois 61822, United States
COAST Investigational Site
New Albany, Indiana 47150, United States
COAST Investigational Site
Lenexa, Kansas 66215, United States
COAST Investigational Site
Prairie Village, Kansas 66208, United States
COAST Investigational Site
West Monroe, Louisiana 71291, United States
COAST Investigational Site
Hagerstown, Maryland 21740, United States
COAST Investigational Site
Owings Mills, Maryland 21117, United States
COAST Investigational Site
Boston, Massachusetts 02114, United States
COAST Investigational Site
Worcester, Massachusetts 01605, United States
COAST Investigational Site
Jackson, Mississippi 39202, United States
COAST Investigational Site
Independence, Missouri 64055, United States
COAST Investigational Site
St Louis, Missouri 63128, United States
COAST Investigational Site
Edison, New Jersey 08820, United States
COAST Investigational Site
Albuquerque, New Mexico 87109, United States
COAST Investigational site
Shirley, New York 11967, United States
COAST Investigational Site
Asheville, North Carolina 28803, United States
COAST Investigational Site
Wilmington, North Carolina 28401, United States
COAST Investigational Site
Winston-Salem, North Carolina 27157, United States
COAST Investigational Site
Cincinnati, Ohio 45202, United States
COAST Investigational Site
Dayton, Ohio 45459, United States
COAST Investigational Site
Oklahoma City, Oklahoma 73102, United States
COAST Investigational Site
Springfield, Oregon 97477, United States
COAST Investigational Site
Kingston, Pennsylvania 18704, United States
COAST Investigational Site
Philadelphia, Pennsylvania 19107, United States
COAST Investigational Site
Greenville, South Carolina 29605, United States
COAST Investigational Site
West Columbia, South Carolina 29169, United States
COAST Investigational Site
Rapid City, South Dakota 57701, United States
COAST Investigational Site
Germantown, Tennessee 38138, United States
COAST Investigational Site
Knoxville, Tennessee 37922, United States
COAST Investigational Site
Abilene, Texas 79606, United States
COAST Investigational Site
Austin, Texas 78705, United States
COAST Investigational Site
Burleson, Texas 76028, United States
COAST Investigational Site
Conroe, Texas 77384, United States
COAST Investigational Site
Dallas, Texas 75243, United States
COAST Investigational Site
Plano, Texas 75075, United States
COAST Investigational Site
Round Rock, Texas 78681, United States
COAST Investigational Site
Fairfax, Virginia 22031, United States
COAST Investigational Site
Bellevue, Washington 98004, United States
COAST Investigational Site
Spokane, Washington 99204, United States
COAST Investigational Site
Morgantown, West Virginia 26505, United States
COAST Investigational Site
Rosario, Santa Fe Province S2000CTC, Argentina
COAST Investigational Site
Rosario, Sante Fe S2000DSK, Argentina
COAST Investigational Site
Ciudad Autonoma de Buenos Aire, C1023AAQ, Argentina
COAST Investigational Site
Ciudad Autonoma de Buenos Aire, C1061AAE, Argentina
COAST Investigational Site
Ciudad Autonoma de Buenos Aire, C1116ABA, Argentina
COAST Investigational Site
Mendoza, 5500, Argentina
COAST Investigational Site
Liverpool, New South Wales 2127, Australia
COAST Investigational Site
Parramatta, New South Wales 2150, Australia
COAST Investigational Site
Strathfield, New South Wales 2135, Australia
COAST Investigational Site
Adelaide, South Australia 5000, Australia
COAST Investigational Site
East Melbourne, Victoria 3002, Australia
COAST Investigational Site
Rowville, Victoria 3178, Australia
COAST Investigational Site
Graz, 8036, Austria
COAST Investigational Site
Belo Horizonte, Minas Gerais 30330-000, Brazil
COAST Investigational Site
Porto Alegre, Rio Grande do Sul 90410-000, Brazil
COAST Investigational Site
São Paulo, 01427-002, Brazil
COAST Investigational Site
São Paulo, 04038-032, Brazil
COAST Investigational Site
São Paulo, 04084-002, Brazil
COAST Investigational Site
Sofia, 1431, Bulgaria
COAST Investigational Site
Stara Zagora, 6000, Bulgaria
COAST Investigational Site
Brampton, Ontario L6Y 0P6, Canada
COAST Investigational Site
North York, Ontario M3C 0GP, Canada
COAST Investigational Site
Ottawa, Ontario K1H 8L6, Canada
COAST Investigational Site
Ottawa, Ontario K2B7E9, Canada
COAST Investigational Site
Medellín, Antioquia 50016, Colombia
COAST Investigational Site
Bogotá, Cundinamarca 110121, Colombia
COAST Investigational Site
Cali, Valle del Cauca Department 760042, Colombia
COAST Investigational Site
Barranquilla, 80002, Colombia
COAST Investigational Site
Bogotá, 110231, Colombia
COAST Investigational Site
Cali, 760036, Colombia
COAST Investigational Site
Medellín, 5001, Colombia
COAST Investigational Site
Osijek, 31000, Croatia
COAST Investigational Site
Osijek, 3100, Croatia
COAST Investigational Site
Split, 21000, Croatia
COAST Investigational Site
Zagreb, 1000, Croatia
COAST Investigational Site
Hradec Králové, Cech Republic, Czechia
COAST Investigational Site
Brno, 625 00, Czechia
COAST Investigational Site
Prague, 100 34, Czechia
COAST Investigational Site
Prague, 12808, Czechia
COAST Investigational Site
Prague, 15000, Czechia

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References and documents

Study documents

Study protocol ↗ · Dec 19, 2023
Statistical analysis plan ↗ · Dec 19, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Mar 2025, 48 months.

Results were first posted in Aug 2025, 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 12, 2021
First posted: Feb 17, 2021
StartActual: Mar 12, 2021
Primary completionActual: Mar 31, 2025
CompletionActual: Mar 31, 2025
Results first posted: Aug 5, 2025
Last update: Aug 5, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04757636
Lead sponsor: Opthea Limited
Responsible party: Sponsor
First posted: Feb 17, 2021
Start date: Mar 12, 2021
Primary completion: Mar 31, 2025
Completion: Mar 31, 2025
Results posted: Aug 5, 2025
Last update: Aug 5, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Sozinibercept

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Other studies from this sponsor

Opthea Limited

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