Wet Age-related Macular DegenerationPhase 1NCT03790852
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
A Phase 1 study testing KSI-301 in people with Wet Age-related Macular Degeneration and Retinal Vein Occlusion, run by Kodiak Sciences Inc at 11 sites in United States.
Trial summary
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
- What is being tested?
- KSI-301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 11 sitesUnited States
- Study dates
- 26 Dec 2018to 9 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wet AMD Cohort
- Treatment naïve wet age-related macular degeneration involving the fovea.
- A lesion area <30 mm2 (12 disc areas) of any lesion type.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
- DME Cohort
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- Treatment naïve diabetic macular edema.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
- Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
- RVO Cohort
- Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
- Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible.
- Decrease in vision in the study eye determined by the investigator to be primarily the result of macular edema secondary to RVO.
- General Inclusion Criteria
- Adults ≥ 21 years.
Who cannot join
- Wet AMD Cohort:
- Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
- Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
- Prior intravitreal anti-VEGF therapy in the study eye.
- DME Cohort:
- Initial diagnosis of DME of more than 6 months from screening in the study eye.
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- Hard exudates in the fovea.
- Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
- Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
- Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.
- RVO Cohort:
- Initial diagnosis of RVO of more than 4 months from screening in the study eye.
- Active retinal or iris neovascularization in the study eye.
- Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
- For all phase 1b subjects:
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of uveitis in either eye.
- Significant media opacities, including visually significant cataract, in the study eye that might interfere with visual acuity assessments, optical coherence tomography, fundus photography, or with examination of the eye for assessment of safety.
- Prior vitrectomy surgery in the study eye.
- Active retinal disease other than the conditions under investigation.
- Active ocular or periocular infection or inflammation in either eye.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Austin Clinical Research
Austin, Texas, 78750
Retina Consultants of Texas
Bellaire, Texas, 77401
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Byers Eye Institute at Stanford
Palo Alto, California, 94303
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
Sierra Eye Associates
Reno, Nevada, 89502
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina Consultants of Texas Woodlands
The Woodlands, Texas, 77384
About this study
Official title: A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
- Being tested
- KSI-301
- Keywords
- DME, wAMD, RVO, KSI-301, Kodiak
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSI-301Drug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| KSI-301 2.5 mg | Experimental | KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria Receives: Drug: KSI-301 |
| KSI-301 5 mg | Experimental | KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria Receives: Drug: KSI-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular (study eye) and systemic adverse events
Measured: Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start26 Dec 2018
- Primary completion2 Jun 2021
- Study completion9 Jun 2022
Why it stopped: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kodiak Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Velazquez-Martin, MD, Study director, Kodiak Sciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790852
- Sponsor's protocol ID
- KSI-CL-101
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2018
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT03790852
- Acronym / sponsor ID
- KSI-CL-101
- Keywords
- DME, wAMD, RVO, KSI-301, Kodiak
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Kodiak Sciences IncIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KSI-301 2.5 mg | Experimental | Drug: KSI-301KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria |
| KSI-301 5 mg | Experimental | Drug: KSI-301KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Wet AMD Cohort
- Treatment naïve wet age-related macular degeneration involving the fovea.
- A lesion area <30 mm2 (12 disc areas) of any lesion type.
- BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
- Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
Key exclusion criteria (22 listed)
- Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
- Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
- Prior intravitreal anti-VEGF therapy in the study eye.
- Initial diagnosis of DME of more than 6 months from screening in the study eye.
- Hard exudates in the fovea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSI-301Intravitreal injection | Drug | KSI-301 2.5 mg, KSI-301 5 mg |
Primary outcome
Incidence of ocular (study eye) and systemic adverse events
Time frame: Week 72
Results and safety
The study was stopped early (reason given: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Velazquez-Martin, MD study director
Kodiak Sciences Inc
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KSI-301 in people with Wet Age-related Macular Degeneration and Retinal Vein Occlusion, run by Kodiak Sciences Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular (study eye) and systemic adverse events (time frame: Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.