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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004409-42 | EudraCT Number |
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This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).
This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety & immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular degeneration.
Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: LUBT010 (proposed ranibizumab biosimilar) | Experimental |
| |
| Drug: Lucentis (ranibizumab) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUBT010 (proposed ranibizumab biosimilar) | Drug | LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months | Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement | Baseline and 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point | Baseline and 3 Months |
| Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
Other In-/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Bruce A. Segal, MD, PA |
There is not a plan to make Individual Participant Data (IPD) available.
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[Not Specified]
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| ID | Title | Description |
|---|---|---|
| FG000 | LUBT010 (Proposed Ranibizumab Biosimilar) | 0.5 mg via intravitreal injection once monthly |
| FG001 | Lucentis (Ranibizumab) | 0.5 mg via intravitreal injection once monthly |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2022 |
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| Lucentis (ranibizumab) | Drug | Lucentis® 0.5 mg via intravitreal injection once monthly |
|
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point |
| Baseline and 6 Months |
| Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point | Baseline and 9 Months |
| Delray Beach |
| Florida |
| 33484 |
| United States |
| Cumberland Valley Retina Consultants, P.C. | Hagerstown | Maryland | 21740 | United States |
| UPMC Eye Center - Eye and Ear Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Oxycom EOOD | Burgas | 8000 | Bulgaria |
| Eye medical center - Visus | Gorna Oryahovitsa | 5100 | Bulgaria |
| University First MHAT-Sofia, St. Joan Krastitel EAD | Sofia | 1142 | Bulgaria |
| MC Ophta-Nevro | Sofia | 1172 | Bulgaria |
| Specialized Eye Hospital Pentagram | Sofia | 1319 | Bulgaria |
| DCC Alexandrovska, EOOD | Sofia | 1431 | Bulgaria |
| Military Medical Academy - MHAT | Sofia | 1606 | Bulgaria |
| Specialized Hospital for Active Treatment of Ophthalmologic Diseases Zora, OOD | Sofia | 1784 | Bulgaria |
| MHAT Trakia, EOOD | Stara Zagora | 6000 | Bulgaria |
| Medical Center Vereya EOOD | Stara Zagora | 6008 | Bulgaria |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz | Győr | 9024 | Hungary |
| The Eye Care Center | Guwahati | Assam | 781003 | India |
| Drishtipunj Eye Hospital Pvt Ltd | Patna | Bihar | 801503 | India |
| Advance Retina Care | Ahmedabad | Gujarat | 380005 | India |
| Sadguru Netra Chikitsalaya | Ahmedabad | Gujarat | 380005 | India |
| Netralaya - Super Speciality Eye Hospital | Ahmedabad | Gujarat | 380006 | India |
| Rising Retina Clinic | Ahmedabad | Gujarat | 380015 | India |
| Government Eye Hospital M & J Institute of Ophthalmology | Ahmedabad | Gujarat | 380016 | India |
| M & J Western Regional Institute of Ophthalmology | Ahmedabad | Gujarat | 380016 | India |
| P N Desai Eye Hospital | Ahmedabad | Gujarat | 380052 | India |
| Kanoria Hospital and Research Center | Gandhinagar | Gujarat | 382428 | India |
| Shivam Retina Clinic and Eye Hospital | Surat | Gujarat | 395001 | India |
| Kiran Hospital Multi Super Speciality Hospital & Research Centre | Surat | Gujarat | 395004 | India |
| Kashyap Memorial Eye Hospital Pvt. Ltd. | Ranchi | Jharkhand | 834001 | India |
| Nethra Eye Hospital | Bangalore | Karnataka | 560094 | India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| JSS Hospital | Mysore | Karnataka | 570004 | India |
| Regional Institute of Opthalmology | Trivandrum | Kerala | 695035 | India |
| Deshmukh Eye Hospital | Amravati | Maharashtra | 444601 | India |
| Kamalnayan Bajaj Hospital | Aurangabad | Maharashtra | 431010 | India |
| Aditya Jyot Eye Hospital Pvt. Ltd. | Mumbai | Maharashtra | 400031 | India |
| Shroff Eye Hospital & Vision Research Centre | Mumbai | Maharashtra | 400050 | India |
| Kenia Eye Hospital | Mumbai | Maharashtra | 400054 | India |
| Anideep Eye Hospital | Mumbai | Maharashtra | 400056 | India |
| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital | Mumbai | Maharashtra | 400056 | India |
| Ambade Eye Hospital | Nagpur | Maharashtra | 440017 | India |
| Dhadiwal Hospital in Coalition with Shreeji Healthcare | Nashik | Maharashtra | 422002 | India |
| Vijay Vallabh Hospital and Medical Research Center | Pālghar | Maharashtra | 401303 | India |
| Dr. D. Y. Patil Medical College | Pune | Maharashtra | 411018 | India |
| Insight Institute of Ophthalmology | Pune | Maharashtra | 411039 | India |
| Sri Guru Ram Das Institute of Medical Sciences & Research | Amritsar | Punjab | 143501 | India |
| Advanced Eye Centre Post Graduate Institute of Medical Education & Research | Chandigarh | Punjab | 160012 | India |
| Dr.Agarwal's Eye Hospital | Tirunelveli | Tamil Nadu | 627003 | India |
| Dr. J L Rohatgi Memorial Eye Hospital | Kanpur | Uttar Pradesh | 208005 | India |
| King George's Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Sam Eye Hospital | Lucknow | Uttar Pradesh | Sam Eye Hospital | India |
| R.K.Netralaya Eye Hospital (P) Ltd. | Varanasi | Uttar Pradesh | 221010 | India |
| Regional Institute of Ophthalmology | Kolkata | West Bengal | 700073 | India |
| Dr. Shroff's Charity Eye Hospital | New Delhi | 110002 | India |
| Sir Ganga Ram Hosptial | New Delhi | 110060 | India |
| Aakash Healthcare Super Specialty Hospital | New Delhi | 110075 | India |
| Szpital Świętego Łukasza S. A. | Bielsko-Biala | 43309 | Poland |
| Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz | 85-157 | Poland |
| Prywatna Klinika Okulistyczna OFTALMIKA | Bydgoszcz | 85-631 | Poland |
| Provisus Badania Kliniczne Sp. z o.o. | Częstochowa | 42-209 | Poland |
| Clinical Medical Research Sp. z o.o. | Katowice | 40-156 | Poland |
| Gabinet Okulistyczny prof. Edward Wylegala | Katowice | 40-594 | Poland |
| ETG Lodz | Lodz | 90-302 | Poland |
| CaminoMed - Specjalistyczne Gabinety Lekarskie | Tarnowskie Góry | 42-600 | Poland |
| LLC HI Optic-Center | Chelyabinsk | 454007 | Russia |
| RSHI State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| BHI of Omsk region Clinical Ophthalmology Hospital n.a V.P. Vykhodtsev | Omsk | 644024 | Russia |
| Standard Clinic Penza LLC | Penza | 440026 | Russia |
| LLC X7 Clinical research | Saint Petersburg | 194156 | Russia |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banská Bystrica | 97517 | Slovakia |
| Nemocnica svateho Michala | Bratislava | 81108 | Slovakia |
| Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava | 82601 | Slovakia |
| Fakultna nemocnica s poliklinikou Nove Zamky | Nové Zámky | 94001 | Slovakia |
| Nemocnica Poprad a.s. | Poprad | 05801 | Slovakia |
| Nemocnica s poliklinikou Trebisov a.s. | Trebišov | 07501 | Slovakia |
| Fakultna nemocnica Trencin | Trenčín | 91101 | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | 01001 | Slovakia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
[Not Specified]
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| ID | Title | Description |
|---|---|---|
| BG000 | LUBT010 (Proposed Ranibizumab Biosimilar) | 0.5 mg via intravitreal injection once monthly |
| BG001 | Lucentis (Ranibizumab) | 0.5 mg via intravitreal injection once monthly |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months | Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement | Full Analysis Set | Posted | Least Squares Mean | Standard Error | Letters | Baseline and 12 Months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point | Full Analysis Set | Posted | Mean | Standard Deviation | Letters | Baseline and 3 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point | Full Analysis Set | Posted | Mean | Standard Deviation | Letters | Baseline and 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months | ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point | Full Analysis Set | Posted | Mean | Standard Deviation | Letters | Baseline and 9 Months |
|
|
AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
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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 | LUBT010 (Proposed Ranibizumab Biosimilar) | 0.5 mg via intravitreal injection once monthly | 3 | 299 | 26 | 299 | 21 | 299 |
| EG001 | Lucentis (Ranibizumab) | 0.5 mg via intravitreal injection once monthly | 4 | 301 | 23 | 301 | 26 | 301 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Normocytic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Macular hole | Eye disorders | Systematic Assessment |
| ||
| Neovascular age-related macular degeneration | Eye disorders | Systematic Assessment |
| ||
| Non-infectious endophthalmitis | Eye disorders | Systematic Assessment |
| ||
| Retinal detachment | Eye disorders | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Inguinal hernia, obstructive | Gastrointestinal disorders | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Ulcerative gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Systemic infection | Infections and infestations | Systematic Assessment |
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| Cataract traumatic | Injury, poisoning and procedural complications | Systematic Assessment |
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| Comminuted fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tuberculin test positive | Investigations | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
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| Varicose vein | Vascular disorders | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neovascular age-related macular degeneration | Eye disorders | Systematic Assessment |
|
[Not Applicable]
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director: Lupin | Lupin | 020-66749100 | 49068 | chiragshah@lupin.com |
| Dec 15, 2025 |
| Prot_SAP_000.pdf |
| 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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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
|