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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg |
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| Cohort 2 | Experimental | Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg |
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| Cohort 3 | Experimental | Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg |
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| Cohort 4 | Experimental | Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacincaptad Pegol | Drug | Avacincaptad Pegol in combination with Lucentis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Adverse Events | Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage) | 6 months |
| Ophthalmic Adverse Events | Number of participants with ophthalmic Adverse Events (with calculated percentage) | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline - ECG | Number of patients with a change on their Month 6 ECG when compared to their baseline ECG | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute | Phoenix | Arizona | 85053 | United States | ||
| Retina Centers PC |
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| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
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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/.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg |
| FG001 | Cohort 2 | Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2017 | Dec 8, 2021 |
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| Lucentis | Drug | Avacincaptad Pegol in combination with Lucentis |
|
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| 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. | 6 months |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Retina Associates SW, PC | Tucson | Arizona | 85710 | United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95841 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| Colorado Retina Associates | Golden | Colorado | 80214 | United States |
| Florida Eye Clinic | Altamonte Springs | Florida | 32701 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Illinois Eye Center | Peoria | Illinois | 61615 | United States |
| Vitreo Retinal Consultants & Surgeons | Wichita | Kansas | 67214 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| VitreoRetinal Surgery | Minneapolis | Minnesota | 55435 | United States |
| Retina Consultants of Nevada | Henderson | Nevada | 89052 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Retina Vitreous Surgeons of CNY, PC | Syracuse | New York | 13224 | United States |
| Retina Northwest PC | Portland | Oregon | 97221 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Strategic Clinical Research Group | Willow Park | Texas | 76087 | United States |
| Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont | Budapest | 1076 | Hungary |
| Budapest Retina Associates | Budapest | 1133 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika | Szeged | 6702 | Hungary |
| Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology | Riga | LV-1002 | Latvia |
| Dr. Solomatin's eye rehabilitation and vision correction centre | Riga | LV-1050 | Latvia |
| FG002 | Cohort 3 | Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis) |
| FG003 | Cohort 4 | Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg |
| BG001 | Cohort 2 | Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day) |
| BG002 | Cohort 3 | Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis) |
| BG003 | Cohort 4 | Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| ETDRS Visual Acuity -Study Eye | Visual Acuity reported as the number of letters read on the ETDRS chart by the study eye | Mean | Standard Deviation | number of letters read |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systemic Adverse Events | Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage) | Safety Population | Posted | Count of Participants | Participants | 6 months |
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| Primary | Ophthalmic Adverse Events | Number of participants with ophthalmic Adverse Events (with calculated percentage) | Safety Population | Posted | Count of Participants | Participants | 6 months |
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| Other Pre-specified | Change From Baseline - ECG | Number of patients with a change on their Month 6 ECG when compared to their baseline ECG | Posted | Count of Participants | Participants | 6 months |
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| Other Pre-specified | 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. | safety population | Posted | Mean | Standard Deviation | number of letters read | 6 months |
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| Other Pre-specified | 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. | safety population | Posted | Mean | Standard Deviation | mm Hg | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4 mg | 0 | 10 | 0 | 10 | 10 | 10 |
| EG001 | Cohort 2 | Monthly administration of Zimura 2 mg + Lucentis 0.5 mg (given on the same day) | 0 | 10 | 1 | 10 | 7 | 10 |
| EG002 | Cohort 3 | Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis) | 0 | 22 | 0 | 22 | 10 | 22 |
| EG003 | Cohort 4 | Zimura 2 mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2 mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2 mg + Lucentis 0.5 mg (Total: 6 doses of Zimura & 3 doses Lucentis) | 0 | 22 | 2 | 22 | 13 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
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| Vitamin B complex deficiency | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
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| Retinal artery occlusion | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Subretinal fibrosis | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vitreous opacities | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
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| cataract | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Neovascular age-related macular degeneration | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
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Institution/PI agrees not to individually publish the results of the Study without IVERIC bio's prior written consent. Institution/PI may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of IVERIC bio.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hersh Patel, OD / Zimura Medical Director | IVERIC bio, Inc | 609-474-6755 | clinicaltrials@ivericbio.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Dec 8, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hungary |
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| United States |
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| Related to study drugs |
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Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) |
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