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CompletedNCT05131646Updated Mar 4, 2024Results posted

Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study

An observational study in Neovascular Age-related Macular Degeneration, sponsored by Clearside Biomedical, Inc.. Completed at 7 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.

Sponsored by Clearside Biomedical, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
50 Years and older
Sex
All
01

Study summary

This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.

Read the detailed description

This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.

Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.

02

Conditions studied

  • Neovascular Age-related Macular Degeneration

Keywords

  • AMD
  • Wet-AMD
  • suprachoroidal
  • tyrosine kinase inhibitor
  • nAMD
  • SCS
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 15 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants who completed cohort 2 or 3 or 4 of CLS1002-101

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.

Exclusion criteria

Exclusion Criteria:

  • Received prohibited medication in the Parent study, CLS1002-101.
  • Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
  • Females of who are pregnant and or lactating.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 2 (Low-mid Dose) Extension

    Subjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.

    Drug: CLS-AX

  • Cohort 3 (High-mid Dose) Extension

    Subjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.

    Drug: CLS-AX

  • Cohort 4 (High Dose) Extension

    Subjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.

    Drug: CLS-AX

Interventions

  • DrugCLS-AX

    injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101

    Also known as: axitinib injectable suspension

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.

    Time frame: Day 1 to Week 24

  2. Number of Participants With Serious Adverse Events (SAEs)

    The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.

    Time frame: Day 1 to Week 24

Secondary outcomes

  1. Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye

    Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A central reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.

    Time frame: Weeks 4, 8, 12, 16, 20 and 24

  2. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye

    BCVA measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.

    Time frame: Weeks 4, 8, 12, 16, 20 and 24

  3. Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

    Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.

    Time frame: Day 1 to Week 24

Other outcomes

  1. Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections

    Number of participants qualifying to receive additional intravitreal aflibercept injections during the course of the study. Criteria included 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness \>75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye.

    Time frame: Day 1 to Week 24

  2. Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)

    Intraocular pressure (IOP) is a diagnostic measurement of the fluid pressure, measured in millimeters of mercury, inside the eye. IOP was measured using Goldmann applanation tonometry or by use of a Tonopen tonometer. Normal eye pressure is usually considered to be between 10 and 20 mmHg (AAO.org). Untreated elevated eye pressure is a risk factor for glaucoma.

    Time frame: Weeks 4, 8, 12, 16, 20 and 24

07

Results

Posted Mar 4, 2024

Participant flow

Participant flow — Overall Study
MilestoneCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Started375
Safety population375
Completed275
Not completed100
Withdrew: Withdrawal by subject100

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.

Time frame:
Day 1 to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Number of Participants With Treatment-emergent Adverse Events (TEAEs)321
PrimaryNumber of Participants With Serious Adverse Events (SAEs)

The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.

Time frame:
Day 1 to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
ParticipantsCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Number of Participants With Serious Adverse Events (SAEs)000
SecondaryMean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A central reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.

Time frame:
Weeks 4, 8, 12, 16, 20 and 24
Reported as:
Mean · microns
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
micronsCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Week 414.7 ± 14.4723.5 ± 23.8220.2 ± 26.64
Week 85.7 ± 30.3728.2 ± 21.4813.6 ± 18.08
Week 1253.3 ± 83.3436.6 ± 34.0219.4 ± 16.10
Week 1618.0 ± 19.805.1 ± 28.2613.4 ± 15.49
Week 2067.020.0 ± 21.8426.2 ± 49.55
Week 246.020.4 ± 33.1026.4 ± 65.26
SecondaryMean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye

BCVA measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.

Time frame:
Weeks 4, 8, 12, 16, 20 and 24
Reported as:
Mean · letters
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
lettersCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Week 40.7 ± 2.081.0 ± 2.190.8 ± 2.49
Week 8-2.3 ± 2.082.5 ± 3.081.8 ± 2.86
Week 12-5.0 ± 10.82-0.9 ± 2.850.0 ± 3.16
Week 16-2.0 ± 0.001.9 ± 3.021.0 ± 4.85
Week 200.0 ± 1.410.0 ± 2.651.0 ± 6.20
Week 24-35.0 ± 46.67-1.9 ± 5.050.4 ± 6.62
SecondaryNumber of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.

Time frame:
Day 1 to Week 24
Reported as:
Count of participants · Participants
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
ParticipantsCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Week 4101
Week 8100
Week 12111
Week 16000
Week 20102
Week 24021
Day 1 to Week 24323
Other pre-specifiedNumber of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections

Number of participants qualifying to receive additional intravitreal aflibercept injections during the course of the study. Criteria included 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness \>75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye.

Time frame:
Day 1 to Week 24
Reported as:
Count of participants · Participants
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
ParticipantsCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Week 4101
Week 8100
Week 12111
Week 16000
Week 20102
Week 24121
Day 1 to Week 24323
Other pre-specifiedMean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)

Intraocular pressure (IOP) is a diagnostic measurement of the fluid pressure, measured in millimeters of mercury, inside the eye. IOP was measured using Goldmann applanation tonometry or by use of a Tonopen tonometer. Normal eye pressure is usually considered to be between 10 and 20 mmHg (AAO.org). Untreated elevated eye pressure is a risk factor for glaucoma.

Time frame:
Weeks 4, 8, 12, 16, 20 and 24
Reported as:
Mean · mmHg
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
mmHgCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Week 4-0.7 ± 4.16-0.5 ± 0.840.2 ± 5.45
Week 80.3 ± 3.790.2 ± 1.721.6 ± 3.78
Week 120.3 ± 2.31-0.1 ± 1.680.2 ± 3.90
Week 160.5 ± 3.540.4 ± 1.721.2 ± 2.49
Week 201.0 ± 0.00-0.6 ± 0.980.0 ± 3.54
Week 24-1.0 ± 4.240.6 ± 1.990.4 ± 3.91

Adverse events

Collected over Adverse events were collected over 24 weeks following CLS-AX administration.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 2 (Low-mid Dose) Extension0/3 (0%)0/3 (0%)3/3 (100%)
Cohort 3 (High-mid Dose) Extension0/7 (0%)0/7 (0%)2/7 (28.6%)
Cohort 4 (High Dose) Extension0/5 (0%)0/5 (0%)1/5 (20%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventCohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) Extension
Macular degenerationEye disorders1/30/70/5
Retinal haemorrhageEye disorders1/31/70/5
Subretinal fluidEye disorders1/30/70/5
CystitisInfections and infestations1/30/70/5
Upper limb fractureInjury, poisoning and procedural complications1/30/70/5
Transient ischaemic attackNervous system disorders1/30/70/5
Ventricular extrasystolesCardiac disorders0/30/71/5
COVID-19Infections and infestations0/30/71/5
PneumoniaInfections and infestations0/30/71/5
Conjunctival haemorrhageEye disorders0/31/70/5

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
Mean78.7 ± 9.0287.9 ± 4.9879.6 ± 3.9783.3 ± 6.82
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
Female25411
Male1214
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
Hispanic or Latino0000
Not Hispanic or Latino37515
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White37515
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
United States37515
Duration of nAMD Diagnosis in the Study Eye
Duration of nAMD Diagnosis in the Study Eye(months)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
Mean56.63 ± 23.75967.29 ± 44.32936.42 ± 38.95554.87 ± 39.442
Total Number of Prior nAMD Treatments in the Study Eye
Total Number of Prior nAMD Treatments in the Study Eye(Participants)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
0-2 Injections0000
3-6 Injections0213
7-12 Injections1012
13-18 Injections0101
>18 Injections2439
Pre Injection Intraocular Pressure in the Study Eye at Baseline
Pre Injection Intraocular Pressure in the Study Eye at Baseline(mmHg)Cohort 2 (Low-mid Dose) ExtensionCohort 3 (High-mid Dose) ExtensionCohort 4 (High Dose) ExtensionTotal
Mean14.3 ± 1.5313.9 ± 2.3413.8 ± 3.5613.9 ± 2.52

2 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • Retinal Consultants of Arizona
    Phoenix, Arizona 85014, United States
  • Northern California Retina Vitreous Associates Medical Group, LLC
    Mountain View, California 94040, United States
  • Retina Consultants Medical Group, Inc
    Sacramento, California 95825, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • Cumberland Valley Retina Consultants
    Hagerstown, Maryland 21740, United States
  • Retina Consultants of Texas
    Bellaire, Texas 77401, United States
  • Retina Consultants of Texas
    The Woodlands, Texas 77384, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Jan 2023, 14 months.

Results were first posted in Mar 2024, 1 year 1 month after primary completion.

Of 56 industry-sponsored observational studies under Macular Degeneration, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 69. This study's 14 months is below that.

Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2021
First posted
Nov 23, 2021
StartActual
Oct 8, 2021
Primary completionActual
Jan 5, 2023
CompletionActual
Jan 5, 2023
Results first posted
Mar 4, 2024
Last update
Mar 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05131646
Lead sponsor
Clearside Biomedical, Inc.
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Oct 8, 2021
Primary completion
Jan 5, 2023
Completion
Jan 5, 2023
Results posted
Mar 4, 2024
Last update
Mar 4, 2024

Study contacts

Susan Coultas, PhD
study director · Clearside Biomedical, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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