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| Name | Class |
|---|---|
| Trial Runners, LLC | OTHER |
| Duke University | OTHER |
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A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema
To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema
- Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).
Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luminate 1.0mg group | Active Comparator | Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. |
|
| Luminate 2.0mg group | Active Comparator | Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. |
|
| Luminate 3.0mg group | Active Comparator | Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. |
|
| Avastin® group | Active Comparator | Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luminate 1.0mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BCVA at Week 24 | Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline | Value of 24 Weeks minus baseline value |
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Inclusion Criteria:
Male or female, 18 years of age or older.
Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
Intra-Ocular Pressure (IOP) is under control (i.e., IOP
≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
Willing and able to return for all study visits.
Able to meet the extensive post-op evaluation regimen.
Understands and signs the informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicken Karageozian | Cheif Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| Retina Vitreous Associates Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Luminate 1.0mg Group | Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 1.0mg |
| 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 | Mar 7, 2016 | Oct 2, 2018 |
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| Avastin then Luminate 1.0 mg IVT + sham injection | Active Comparator | Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT |
|
| Avastin then Luminate 0.5 mg IVT + sham injection | Active Comparator | Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT |
|
| Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT | Active Comparator | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT |
|
| Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT | Active Comparator | Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT |
|
| Avastin 1.25 mg + Sham IVT | Active Comparator | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN |
|
| Luminate 2.0mg | Drug |
|
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| Luminate 3.0mg | Drug |
|
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| Avastin | Drug |
|
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| Luminate 0.5mg | Drug |
|
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| West Coast Retina | San Francisco | California | 94109 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| New England Retina Associates | New London | Connecticut | 06320 | United States |
| Florida Eye Clinic | Altamonte Springs | Florida | 32701 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Wilmer Eye Institute at John Hopkins University | Baltimore | Maryland | 21205 | United States |
| TLC Eye Group | Jackson | Michigan | 49202 | United States |
| Island Retina | Shirley | New York | 11967 | United States |
| Charlotte EENT Associates | Charlotte | North Carolina | 28210 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultant of Houston | Houston | Texas | 77098 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| FG001 | Luminate 2.0mg Group | Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 2.0mg |
| FG002 | Luminate 3.0mg Group | Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 3.0mg |
| FG003 | Avastin® Group | Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required. Avastin |
| FG004 | Avastin Then Luminate 1.0 mg IVT + Sham Injection | Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin |
| FG005 | Avastin Then Luminate 0.5 mg IVT + Sham Injection | Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg |
| FG006 | Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin |
| FG007 | Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT | Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg |
| FG008 | Avastin 1.25 mg + Sham IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN Luminate 0.5mg |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Luminate 1.0mg Group | Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 1.0mg |
| BG001 | Luminate 2.0mg Group | Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 2.0mg |
| BG002 | Luminate 3.0mg Group | Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 3.0mg |
| BG003 | Avastin® Group | Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required. Avastin |
| BG004 | Avastin Then Luminate 1.0 mg IVT + Sham Injection | Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin |
| BG005 | Avastin Then Luminate 0.5 mg IVT + Sham Injection | Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg |
| BG006 | Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin |
| BG007 | Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT | Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg |
| BG008 | Avastin 1.25 mg + Sham IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN Luminate 0.5mg |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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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 | Change in BCVA at Week 24 | Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline | Posted | Mean | Standard Error | Letters on ETDRS eye chart | Value of 24 Weeks minus baseline value |
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The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 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 | Luminate 1.0mg Group | Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 1.0mg | 1 | 39 | 8 | 39 | 28 | 39 |
| EG001 | Luminate 2.0mg Group | Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 2.0mg | 0 | 33 | 3 | 33 | 20 | 33 |
| EG002 | Luminate 3.0mg Group | Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Luminate 3.0mg | 1 | 42 | 6 | 42 | 25 | 42 |
| EG003 | Avastin® Group | Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required. Avastin | 1 | 24 | 3 | 24 | 16 | 24 |
| EG004 | Avastin Then Luminate 1.0 mg IVT + Sham Injection | Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin | 0 | 19 | 2 | 19 | 10 | 19 |
| EG005 | Avastin Then Luminate 0.5 mg IVT + Sham Injection | Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg | 0 | 17 | 1 | 17 | 5 | 17 |
| EG006 | Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Luminate 1.0mg Avastin | 0 | 13 | 1 | 13 | 6 | 13 |
| EG007 | Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT | Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Avastin Luminate 0.5mg | 0 | 16 | 2 | 16 | 7 | 16 |
| EG008 | Avastin 1.25 mg + Sham IVT | Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN Luminate 0.5mg | 0 | 15 | 3 | 15 | 3 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| eye disorders | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Metabolism and nutritional disorders | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Neoplasms benign malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Respitatory, thoracic and mediastinal | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| general disorders | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| eye disorders | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| gastrointestinal disorders | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| infections and infestations | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Metabolism and nutritional disorders | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
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| musculoskeletal and connective tissue | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| psychiatric disorders | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
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| skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
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| Vascular disorders | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
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Investigator will submit to Sponsor a copy of the proposed publication or presentation and the name of the scientific journal or forum to which it will be submitted- at least ninety (90) days prior to the submission.Investigator shall comply with Sponsor's request to delete references to Confidential Information,in any such paper or presentation and agrees to withhold publication or presentation of same for an additional ninety (90) days in order to permit Sponsor to obtain patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Allegro Ophthalmics, LLC | 949-940-8130 | info@allegroeye.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2017 | Oct 2, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000712274 | risuteganib |
| D000068258 | Bevacizumab |
| 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 |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| American Indian or Alaska Native |
|