Trial Outcomes & Findings for A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (NCT NCT04684394)

Last Updated: 2022-10-31

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline up to Week 48

Results posted on

2022-10-31

Participant Flow

This study was conducted at multiple sites in the United States from 29 December 2020 to 18 February 2022.

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.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	34 68	16 32
Overall Study Study Eye	34 34	16 16
Overall Study Fellow Eye	34 34	16 16
Overall Study COMPLETED	5 10	1 2
Overall Study NOT COMPLETED	29 58	15 30

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	1	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Study discontinued per Sponsor decision	25	13

Baseline Characteristics

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline up to Week 48

Population: The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham).

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=34 Participants 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.	SoC + Sham n=16 Participants 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.
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) Participants with Ocular TEAE in Fellow Eye	6 Participants	3 Participants
Number of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) Participants with Ocular TEAE in Study Eye	11 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 48

Population: The FAS included all randomized participants who received at least 1 dose of study drug (GEM103 or sham).

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=34 Participants 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.	SoC + Sham n=16 Participants 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.
Number of Participants With Non-ocular TEAEs	10 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=29 Participants 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.	SoC + Sham n=13 Participants 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.
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Optic Nerve in Fellow Eye	4 Participants	6 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Vitreous in Study Eye	26 Participants	8 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Vitreous in Fellow Eye	23 Participants	8 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Optic Nerve in Study Eye	4 Participants	5 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Macula in Study Eye	28 Participants	11 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Macula in Fellow Eye	28 Participants	12 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Retina Periphery in Study Eye	5 Participants	2 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Retina Periphery in Fellow Eye	6 Participants	4 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Phakic in Study Eye	5 Participants	4 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Phakic in Fellow Eye	6 Participants	5 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Pseudophakic in Study Eye	24 Participants	9 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Pseudophakic in Fellow Eye	23 Participants	8 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Mild in Study Eye	1 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Mild in Fellow Eye	2 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Moderate in Study Eye	1 Participants	3 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Moderate in Fellow Eye	1 Participants	4 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Severe in Study Eye	2 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Nuclear Cataract: Severe in Fellow Eye	2 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Mild in Study Eye	1 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Mild in Fellow Eye	2 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Moderate in Study Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Moderate in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Severe in Study Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cortical Cataract: Severe in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Mild in Study Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Mild in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Moderate in Study Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Moderate in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Severe in Study Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Posterior Subcapsular Cataract: Severe in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Lids/Lashes findings in Study Eye	4 Participants	2 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Lids/Lashes findings in Fellow Eye	5 Participants	2 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cornea findings in Study Eye	8 Participants	3 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Cornea findings in Fellow Eye	6 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Conjunctiva findings in Study Eye	2 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Conjunctiva findings in Fellow Eye	2 Participants	1 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Iris Pupil findings in Study Eye	2 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Iris Pupil findings in Fellow Eye	0 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Anterior Chamber findings in Study Eye	1 Participants	0 Participants
Number of Participants With Abnormal Ophthalmic Examination Findings Participants With Anterior Chamber findings in Fellow Eye	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=30 Participants 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.	SoC + Sham n=13 Participants 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.
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=15 Letters in Study Eye	0 percentage of participants	0 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=10 Letters in Study Eye	3.3 percentage of participants	0 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=5 Letters in Study Eye	43.3 percentage of participants	15.4 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=15 Letters in Fellow Eye	3.3 percentage of participants	7.7 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=10 Letters in Fellow Eye	6.7 percentage of participants	15.4 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Best Corrected Visual Acuity (BCVA) >=5 Letters in Fellow Eye	23.3 percentage of participants	15.4 percentage of participants

PRIMARY outcome

Timeframe: Baseline up to Week 48

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=30 Participants 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.	SoC + Sham n=13 Participants 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.
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=15 Letters in Study Eye	6.7 percentage of participants	0 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=10 Letters in Study Eye	16.7 percentage of participants	7.7 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=5 Letters in Study Eye	26.7 percentage of participants	53.8 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=15 Letters in Fellow Eye	3.3 percentage of participants	0.0 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=10 Letters in Fellow Eye	6.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Greater Than or Equal to (>=)15, >=10, >=5 Letters From the Baseline in Low Luminance Visual Acuity (LLVA) >=5 Letters in Fellow Eye	10.0 percentage of participants	15.4 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=58 eyes 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.	SoC + Sham n=26 eyes 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.
Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 Both Eyes	-4.73 wpm Standard Error 47.397	3.08 wpm Standard Error 52.499
Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 Study Eye	-21.41 wpm Standard Error 7.070	-30.35 wpm Standard Error 35.707
Mean Change From Baseline in Minnesota Low-vision Reading (MNRead) Test at Week 48 Fellow Eye	-18.86 wpm Standard Error 63.209	-7.88 wpm Standard Error 43.452

SECONDARY outcome

Timeframe: Baseline, Week 32

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=1 eyes 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.	SoC + Sham n=1 eyes 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.
Change From Baseline in Total Complement Factor H (CFH) Concentration in Aqueous Humor	602.890 nanogram per milliliter (ng/mL)	156.520 nanogram per milliliter (ng/mL)

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=60 eyes 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.	SoC + Sham n=26 eyes 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.
Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48 Study Eye	1.0 ETDRS letters Standard Deviation 8.44	-0.4 ETDRS letters Standard Deviation 5.24
Mean Change From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) at Week 48 Fellow Eye	0.0 ETDRS letters Standard Deviation 11.05	0.7 ETDRS letters Standard Deviation 8.10

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: 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.

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).

Outcome measures

Outcome measures
Measure	SoC + GEM103 n=2 eyes 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.	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.
Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) Study Eye	2.170 millimeters squared (mm^2)	—
Mean Change From Baseline in Macular Atrophy (MA) Assessed by Fundus Autofluorescence (FAF) Fellow Eye	2.430 millimeters squared (mm^2)	—

Adverse Events

SoC + GEM103

Serious events: 5 serious events

Other events: 18 other events

Deaths: 1 deaths

SoC + Sham

Serious events: 4 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	SoC + GEM103 n=34 participants at risk 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.	SoC + Sham n=16 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Cardiac disorders Atrial fibrillation	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Gastrointestinal disorders Abdominal pain	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Investigations Haemoglobin decreased	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Nervous system disorders Syncope	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Infections and infestations Urinary tract infection	0.00% 0/34 • 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.	6.2% 1/16 • 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.
Cardiac disorders Cardiac failure acute	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Gastrointestinal disorders Retroperitoneal haemorrhage	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/34 • 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.	6.2% 1/16 • 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.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/34 • 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.	0.00% 0/16 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.9% 1/34 • 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.	12.5% 2/16 • 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.

Other adverse events

Additional Information

Gemini Therapeutics, Inc.

Phone: 617-401-4401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SoC + GEM103 n=34 Participants 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.	SoC + Sham n=16 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	16 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	16 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	16 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants