ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
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ClinicalTrials.gov Identifier: NCT03362190 |
Recruitment Status :
Completed
First Posted : December 5, 2017
Results First Posted : February 2, 2022
Last Update Posted : February 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wet Age-related Macular Degeneration | Drug: Zimura Drug: Lucentis | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration |
Actual Study Start Date : | October 11, 2017 |
Actual Primary Completion Date : | October 18, 2018 |
Actual Study Completion Date : | October 18, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Zimura dosage 1 + Lucentis 0.5 mg
|
Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol Drug: Lucentis Zimura in combination with Lucentis
Other Name: ranibizumab |
Experimental: Cohort 2
Zimura dosage 2 + Lucentis 0.5 mg
|
Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol Drug: Lucentis Zimura in combination with Lucentis
Other Name: ranibizumab |
Experimental: Cohort 3
Zimura dosage 3 + Lucentis 0.5 mg
|
Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol Drug: Lucentis Zimura in combination with Lucentis
Other Name: ranibizumab |
Experimental: Cohort 4
Zimura dosage 4 + Lucentis 0.5 mg
|
Drug: Zimura
Zimura in combination with Lucentis
Other Name: avacincaptad pegol Drug: Lucentis Zimura in combination with Lucentis
Other Name: ranibizumab |
- Systemic Adverse Events [ Time Frame: 6 months ]Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
- Ophthalmic Adverse Events [ Time Frame: 6 months ]Number of participants with ophthalmic Adverse Events (with calculated percentage)
- Change From Baseline - ECG [ Time Frame: 6 months ]Number of patients with a change on their Month 6 ECG when compared to their baseline ECG
- Mean Change From Baseline - Study Eye ETDRS Visual Acuity [ Time Frame: 6 months ]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.
- Mean Change From Baseline - Vital Signs [ Time Frame: 6 months ]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.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Active subfoveal NVAMD
Exclusion Criteria:
- History or evidence of severe cardiac disease
- Any major surgical procedure within one month of trial entry
- Subjects with a clinically significant laboratory value
- Any treatment with an investigational agent in the past 60 days for any condition
- Women who are pregnant or nursing
- Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
- Any prior treatment for AMD other than oral supplements of vitamins and minerals

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362190

Documents provided by IVERIC bio, Inc. ( Ophthotech Corporation ):
Responsible Party: | Ophthotech Corporation |
ClinicalTrials.gov Identifier: | NCT03362190 |
Other Study ID Numbers: |
OPH2007 |
First Posted: | December 5, 2017 Key Record Dates |
Results First Posted: | February 2, 2022 |
Last Update Posted: | February 9, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share individual participant data at this time. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Zimura ARC1905 Lucentis ranibizumab |
Wet AMD avacincaptad pegol complement factor C5 inhibitor |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |