A Phase 2 interventional study of Avacincaptad Pegol and Lucentis in Neovascular Age-related Macular Degeneration, sponsored by Ophthotech Corporation. Completed at 28 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Ophthotech Corporation (part of Astellas Pharma Inc) · Phase 2, Interventional, and Treatment
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 64 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Ophthotech Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Ophthotech Corporation became part of Astellas Pharma Inc.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol · Drug: Lucentis
Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol · Drug: Lucentis
Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol · Drug: Lucentis
Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
Drug: Avacincaptad Pegol · Drug: Lucentis
Avacincaptad Pegol in combination with Lucentis
Also known as: Zimura (previous name), IZERVAY, ARC1905
Avacincaptad Pegol in combination with Lucentis
Also known as: ranibizumab
Systemic Adverse Events
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Time frame: 6 months
Ophthalmic Adverse Events
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Time frame: 6 months
Change From Baseline - ECG
Number of patients with a change on their Month 6 ECG when compared to their baseline ECG
Time frame: 6 months
Mean Change From Baseline - Study Eye ETDRS Visual Acuity
Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
Time frame: 6 months
Mean Change From Baseline - Vital Signs
Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.
Time frame: 6 months
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Started | 10 | 10 | 22 | 22 |
| Completed | 10 | 10 | 22 | 20 |
| Not completed | 0 | 0 | 0 | 2 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| All causalities | 6 | 5 | 5 | 11 |
| Related to study drugs | 0 | 0 | 0 | 0 |
Number of participants with ophthalmic Adverse Events (with calculated percentage)
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Participants with all causality events in the fellow eye | 1 | 1 | 0 | 2 |
| Participants with all causality events in the study eye | 8 | 4 | 11 | 15 |
| Participants with event related to injection procedure in the study eye | 8 | 4 | 10 | 12 |
| Participants with event related to injection procedure in the fellow eye | 0 | 0 | 0 | 0 |
| Participants with event related to study drugs in the study eye | 0 | 0 | 0 | 0 |
| Participants with event related to study drugs in the fellow eye | 0 | 0 | 0 | 0 |
Number of patients with a change on their Month 6 ECG when compared to their baseline ECG
| Participants | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| No Change | 7 | 5 | 18 | 12 |
| Not Clinically Signigicant Change | 3 | 5 | 3 | 6 |
| Clinically Significant Change | 0 | 0 | 0 | 1 |
| Missing | 0 | 0 | 1 | 3 |
Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
| number of letters read | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Mean Change From Baseline - Study Eye ETDRS Visual Acuity | 9.0 ± 11.0 | 10.2 ± 18.7 | 10.7 ± 10.3 | 9.9 ± 8.2 |
Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.
| mm Hg | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Systolic blood pressure (mm Hg) | -12.0 ± 15.04 | 0.7 ± 8.92 | -1.9 ± 14.92 | -5.8 ± 18.24 |
| Diastolic blood pressure (mm Hg) | -3.2 ± 7.93 | -7.9 ± 12.32 | -4.7 ± 11.83 | -0.4 ± 8.24 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Cohort 2 | 0/10 (0%) | 1/10 (10%) | 7/10 (70%) |
| Cohort 3 | 0/22 (0%) | 0/22 (0%) | 10/22 (45.5%) |
| Cohort 4 | 0/22 (0%) | 2/22 (9.1%) | 13/22 (59.1%) |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/10 | 1/10 | 0/22 | 0/22 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/10 | 0/10 | 0/22 | 1/22 |
| Retinal detachmentEye disorders | 0/10 | 0/10 | 0/22 | 1/22 |
| Event | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| Conjunctival haemorrhageEye disorders | 6/10 | 1/10 | 5/22 | 6/22 |
| FallInjury, poisoning and procedural complications | 2/10 | 0/10 | 1/22 | 1/22 |
| ContusionInjury, poisoning and procedural complications | 2/10 | 0/10 | 0/22 | 0/22 |
| Punctate keratitisEye disorders | 2/10 | 1/10 | 1/22 | 1/22 |
| Vitreous floatersEye disorders | 0/10 | 0/10 | 3/22 | 3/22 |
| Eye painEye disorders | 1/10 | 0/10 | 0/22 | 3/22 |
| DiarrhoeaGastrointestinal disorders | 0/10 | 1/10 | 0/22 | 0/22 |
| Hiatus herniaGastrointestinal disorders | 1/10 | 0/10 | 0/22 | 0/22 |
| NasopharyngitisInfections and infestations | 1/10 | 0/10 | 0/22 | 1/22 |
| Upper respiratory tract infectionInfections and infestations | 1/10 | 0/10 | 0/22 | 1/22 |
| Age, Categorical(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 0 | 2 | 1 | 5 |
| >=65 years | 8 | 10 | 20 | 21 | 59 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Mean | 73.7 ± 11.27 | 77.9 ± 6.62 | 74.1 ± 7.41 | 78.1 ± 7.40 | 76.0 ± 8.07 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Female | 4 | 8 | 14 | 12 | 38 |
| Male | 6 | 2 | 8 | 10 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 | 2 |
| Not Hispanic or Latino | 10 | 10 | 21 | 21 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 10 | 10 | 22 | 22 | 64 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Latvia | 0 | 1 | 2 | 3 | 6 |
| Hungary | 0 | 3 | 8 | 2 | 13 |
| United States | 10 | 6 | 12 | 17 | 45 |
| ETDRS Visual Acuity -Study Eye(number of letters read) | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|
| Mean | 53.9 ± 9.0 | 51.5 ± 5.4 | 52.5 ± 9.4 | 53.2 ± 9.9 | 52.8 ± 8.9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Ran from Oct 2017 to primary completion in Oct 2018, 12 months.
Results were first posted in Feb 2022, 3 years 3 months after primary completion. A results delay was requested in Oct 2019.
Of 66 industry-sponsored phase 2 interventional studies under Macular Degeneration, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 12 months is below that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 16 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Avacincaptad pegol