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Sponsor decision
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This study is designed to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.
This is a Phase 2a, multi-center, multiple dose study in subjects with Neovascular Age-related Macular Degeneration (nAMD) to investigate the safety and tolerability of GEM103 IVT injection + standard of care vs. sham + standard of care.
Subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SoC + GEM103 | Experimental | Participants were administered SoC therapy defined as aflibercept (2 milligram [mg]/50 microliter [mcL]) first, followed by GEM103 (500 microgram [mcg]/50mcL) 15 minutes later. Administration occurred every other month (EOM) for a total of 6 doses during the 12-month study period. |
|
| SoC + Sham | Sham Comparator | Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEM103 | Biological | GEM103 500 mcg/50 mcL intravitreal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication. TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration. Number of participants with ocular TEAEs in study eye and fellow eye were reported. | Baseline up to Week 48 |
| Number of Participants With Non-ocular TEAEs | An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication. TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration. Number of participants with non-ocular TEAEs were reported. | Baseline up to Week 48 |
| Number of Participants With Abnormal Ophthalmic Examination Findings | Ophthalmoscopy examination was performed in each eye with findings reported for Vitreous, Optic Nerve, Macula, Retina Periphery. Lens Status and Opacification (Phakic and Pseudophakic) was also performed. Nuclear Cataract, Cortical Cataract, and Posterior Subcapsular Cataract categories was further summarized by severity grade. Ocular biomicroscopic examination was performed with findings reported for Lids/Lashes, Conjunctiva, Cornea, Anterior Chamber, and Iris/Pupil. | Baseline up to Week 48 |
| Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) | Visual function assessments included BCVA assessment in each eye by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The letter score ranges from 0 (worse score) to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants with increase in BCVA with greater than or equal to (>=)15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor | Observed continuous total CFH concentration level in aqueous humor (ng/mL) was analyzed in study eye only by type of biological matrix by treatment group using descriptive statistics. Change from baseline in total CFH Concentration in aqueous humor at Week 32 was reported. | Baseline, Week 32 |
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Inclusion Criteria:
At least 50 years old at the time of signed informed consent
Choroidal neovascularization (CNV) related to nAMD with the following features, as determined by the Image Reading Center
On aflibercept treatment prior to Day 1
Best Corrected Visual Acuity (BCVA) in the study eye between 24 to 75 letters using EDTRS
Exclusion Criteria:
Presence of the following ocular conditions in the study eye:
Presence of any of the following ocular conditions in either eye:
Any prior or ongoing medical condition or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period
Has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent
Females must not be pregnant or lactating
Current use of medications known to be toxic to the lens, retina or optic nerve
Use of any investigational new drug or other experimental treatment in the last 6 months prior to Day 1, and/or receipt of any prior gene therapy or ocular device implantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Clinical Trial Site 16 | Phoenix | Arizona | 85021 | United States | ||
| Gemini Clinical Trial Site 11 |
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A total of 70 participants were screened of which 20 were screen failure. 50 participants were randomized in 2:1 ratio in this study, of which 34 participants received the GEM103 + aflibercept (SoC) and 16 received the Sham + SoC.
This study was conducted at multiple sites in the United States from 29 December 2020 to 18 February 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | SoC + GEM103 | Participants were administered SoC therapy defined as aflibercept (2 milligram [mg]/50 microliter [mcL]) first, followed by GEM103 (500 microgram [mcg]/50mcL) 15 minutes later. Administration occurred every other month (EOM) for a total of 6 doses during the 12-month study period. |
| FG001 |
| 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 | May 5, 2021 | Sep 30, 2022 |
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| Aflibercept |
| Drug |
Aflibercept 2 mg/50 mcL (SOC) intravitreal injection Sham intravitreal injection |
|
| Sham | Drug | Sham intravitreal injection |
|
| Baseline up to Week 48 |
| Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) | Visual function assessments included LLVA assessment in each eye by ETDRS letters. LLVA was measured on the ETDRS chart at a starting distance of 4 meters. The letter score ranges from 0 (worse score) to 100 (best score), and a gain in LLVA from baseline indicates an improvement in visual acuity. For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants with increase in LLVA with >=15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint. | Baseline up to Week 48 |
| Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 | The MNRead acuity cards are continuous-text reading acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. Formula for reading speed words per minute (wpm): reading speed is equal to 60*(10 - errors)/ (time in seconds). A negative change from baseline indicates a decrease in the reading speed; disease worsening. | Baseline, Week 48 |
| Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters in each eye. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. All items were transformed on to total score ranges from 0 to 100 (best score). A negative change indicates no improvement in the condition. | Baseline, Week 48 |
| Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) | MA lesion area was measured in millimeters squared (mm^2) by FAF in each eye. The change in MA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of MA lesion area (worsening; disease progression). | Baseline up to Week 48 |
| Campbell |
| California |
| 95008 |
| United States |
| Gemini Clinical Trial Site 9 | Encino | California | 91436 | United States |
| Gemini Clinical Trial Site 17 | Huntington Beach | California | 92647 | United States |
| Gemini Clinical Trial Site 12 | Pasadena | California | 91107 | United States |
| Gemini Clinical Trial Site 5 | Miami | Florida | 33143 | United States |
| Gemini Clinical Trial Site 7 | Pinellas Park | Florida | 33782 | United States |
| Gemini Clinical Trial Site 20 | Sarasota | Florida | 34239 | United States |
| Gemini Clinical Trial Site 8 | Stuart | Florida | 34994 | United States |
| Gemini Clinical Trial Site 18 | Winter Haven | Florida | 33880 | United States |
| Gemini Clinical Trial Site 19 | Indianapolis | Indiana | 46290 | United States |
| Gemini Clinical Trial Site 4 | Hagerstown | Maryland | 21740 | United States |
| Gemini Clinical Trial Site 23 | Worcester | Massachusetts | 01605 | United States |
| Gemini Clinical Trial Site 22 | Royal Oak | Michigan | 48073 | United States |
| Gemini Clinical Trial Site 1 | Reno | Nevada | 89502 | United States |
| Gemini Clinical Trial Site 2 | Asheville | North Carolina | 28803 | United States |
| Gemini Clinical Trial Site 15 | Charlotte | North Carolina | 28210 | United States |
| Gemini Clinical Trial Site 6 | Cincinnati | Ohio | 45219 | United States |
| Gemini Clinical Trial Site 10 | Eugene | Oregon | 97401 | United States |
| Gemini Clinical Trial Site 13 | Beaufort | South Carolina | 29902 | United States |
| Gemini Clinical Trial Site 3 | Dallas | Texas | 75231 | United States |
| Gemini Clinical Trial Site 21 | San Antonio | Texas | 78240 | United States |
| Gemini Clinical Trial Site 14 | San Antonio | Texas | 78247 | United States |
| SoC + Sham |
Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. |
| Study Eye |
|
| Fellow Eye |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug (GEM103 or sham).
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| ID | Title | Description |
|---|---|---|
| BG000 | SoC + GEM103 | Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by GEM103 (500mcg/50mcL) 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. |
| BG001 | SoC + Sham | Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication. TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration. Number of participants with ocular TEAEs in study eye and fellow eye were reported. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). | Posted | Count of Participants | Participants | Baseline up to Week 48 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Non-ocular TEAEs | An adverse event (AE) was defined as any untoward medical occurrence or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the study, whether related or not to the study medication. TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration. Number of participants with non-ocular TEAEs were reported. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). | Posted | Count of Participants | Participants | Baseline up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Ophthalmic Examination Findings | Ophthalmoscopy examination was performed in each eye with findings reported for Vitreous, Optic Nerve, Macula, Retina Periphery. Lens Status and Opacification (Phakic and Pseudophakic) was also performed. Nuclear Cataract, Cortical Cataract, and Posterior Subcapsular Cataract categories was further summarized by severity grade. Ocular biomicroscopic examination was performed with findings reported for Lids/Lashes, Conjunctiva, Cornea, Anterior Chamber, and Iris/Pupil. | The FAS included all participants who received at least 1 dose of study drug/reference therapy (GEM103 or sham). Here "overall number of participants analyzed" are those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) | Visual function assessments included BCVA assessment in each eye by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The letter score ranges from 0 (worse score) to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants with increase in BCVA with greater than or equal to (>=)15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) | Visual function assessments included LLVA assessment in each eye by ETDRS letters. LLVA was measured on the ETDRS chart at a starting distance of 4 meters. The letter score ranges from 0 (worse score) to 100 (best score), and a gain in LLVA from baseline indicates an improvement in visual acuity. For each participant, an average value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants with increase in LLVA with >=15, >=10, >=5 letters from the baseline per treatment arm who met the endpoint. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 48 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 | The MNRead acuity cards are continuous-text reading acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. Formula for reading speed words per minute (wpm): reading speed is equal to 60*(10 - errors)/ (time in seconds). A negative change from baseline indicates a decrease in the reading speed; disease worsening. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Here, "overall number of participants analyzed, and overall number of units analyzed" signifies those participants and units respectively who were evaluable for this outcome measure and number of participants and units analyzed signifies those who were evaluable for specified categories. | Posted | Mean | Standard Error | wpm | Baseline, Week 48 | eyes | eyes |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor | Observed continuous total CFH concentration level in aqueous humor (ng/mL) was analyzed in study eye only by type of biological matrix by treatment group using descriptive statistics. Change from baseline in total CFH Concentration in aqueous humor at Week 32 was reported. | The biomarker set (BS) included participants with sufficient data to assess biomarker results. Here, "overall number of participants analyzed, and overall number of units analyzed" signifies those participants and units respectively who were evaluable for this outcome measure and number of units analyzed signifies those who were evaluable for specified categories. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline, Week 32 | eyes | eyes |
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48 | BCVA was measured on the ETDRS chart at a starting distance of 4 meters in each eye. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. All items were transformed on to total score ranges from 0 to 100 (best score). A negative change indicates no improvement in the condition. | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Here, "overall number of participants analyzed, and overall number of units analyzed" signifies those participants and units respectively who were evaluable for this outcome measure and number of units analyzed signifies those who were evaluable for specified categories. | Posted | Mean | Standard Deviation | ETDRS letters | Baseline, Week 48 | eyes | eyes |
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) | MA lesion area was measured in millimeters squared (mm^2) by FAF in each eye. The change in MA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of MA lesion area (worsening; disease progression). | The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Here, "overall number of participants analyzed, and overall number of units analyzed" signifies those participants and units respectively who were evaluable for this outcome measure and number of units analyzed signifies those who were evaluable for specified categories. | Posted | Mean | Standard Deviation | millimeters squared (mm^2) | Baseline up to Week 48 | eyes | eyes |
|
From Baseline up to Week 48
The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham). Overall data (Ocular and Non-Ocular) has been reported here.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SoC + GEM103 | Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by GEM103 (500mcg/50mcL) 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. | 1 | 34 | 5 | 34 | 18 | 34 |
| EG001 | SoC + Sham | Participants were administered SoC therapy defined as aflibercept (2mg/50mcL) first, followed by the Sham injection 15 minutes later. Administration occurred EOM for a total of 6 doses during the 12-month study period. | 2 | 16 | 4 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous floaters | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Conjunctival deposit | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Retinal drusen | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Retinopathy hypertensive | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gemini Therapeutics, Inc. | Gemini Therapeutics, Inc. | 617-401-4401 | clinicaltrials@geminitherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2022 | Sep 30, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D012162 | Retinal Degeneration |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
| >=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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