Neovascular Age-Related Macular DegenerationPhase 1NCT02530918
Study of DS-7080a for the Treatment of Macular Degeneration
A Phase 1 study testing DS-7080a and Ranibizumab in people with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema, run by Daiichi Sankyo at 12 sites in United States.
Trial summary
The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- DS-7080a and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2015to 2 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For parts 1 and 2:
- ≥ 50 years of age
- Has active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD)
- CNV ≥ 50% of total lesion size in study eye
- Central sub-field thickness > 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye
- Has BCVA letter score required at screening visit:
Show all 12Show fewer
- For Part 1, ≤ 49 (approximately 20/100 or worse) in the study eye and ≥ 49 (approximately 20/100 or better) in the fellow eye
- For Part 2, 78 to 25 (approximately 20/32 to 20/320) in the study eye
- For Part 3:
- Is ≥ 18 years of age with retinal thickening due to diabetic macular edema (DME)
- Has central sub-field thickness (CST) > 335 μm in the study eye
- Has BCVA letter score at screening visit 78 to 25 letters (approximately 20/32 to 20/320) in the study eye
Who cannot join
- For Parts 1 and 2:
- Has used any long acting steroids, either systemically or intraocularly, within 6 months of Baseline Visit
- Has total lesion size > 12 disc areas (30.5 mm2) in the study eye
- Has presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- Has history of any vitreous hemorrhage within 4 weeks prior to Screening Visit in the study eye
- Has presence of causes of CNV other than AMD
Show all 49Show fewer
- Had prior vitrectomy in the study eye
- Has history of retinal detachment or treatment or surgery for retinal detachment in the study eye
- Has any history of a full thickness macular hole in the study eye
- Had any intraocular or periocular surgery within 3 months of Baseline Visit on the study eye, except lid surgery
- Has uncontrolled glaucoma in the study eye
- Has active intraocular inflammation or periocular infection in either eye
- Has any history of uveitis in either eye of scleromalacia in either eye
- Has aphakia or pseudophakia in the study eye
- Had previous therapeutic radiation in the region of the study eye
- Has history of corneal transplant or corneal dystrophy in the study eye
- Has significant media opacities in the study eye (e.g. cataract) that could require either medical or surgical intervention during the study period
- Is a women who is pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study
- For Part 1 only:
- Had any ocular (in the study eye) or systemic treatment or surgery for neovascular AMD within 4 weeks of Baseline Visit, except dietary supplements or vitamins
- Has a subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye
- Has scarring or fibrosis, making up >50% of total lesion or involving the center of the fovea in the study eye
- For Part 2 only:
- Had any prior therapy in the study eye within 3 months of Baseline Visit, except dietary supplements or vitamins
- For Part 3:
- Has used any steroids, either systemically or ocular in the study eye (other than fluocinolone), within 6 months of Baseline Visit
- Has macular edema in the study eye considered to be due to a cause other than DME
- Has high-risk proliferative diabetic retinopathy (PDR) in the study eye
- Has decrease in BCVA in the study eye due to causes other than DME
- Has significant macular ischemia in the study
- Has choroidal neovascularization (CNV) secondary to any etiology
- Has retinal pigment epithelial tears or rips involving the macula in the study eye
- Had any vitreous hemorrhage within 4 weeks prior to Screening/Visit 1 in the study eye
- Had prior vitrectomy in the study eye
- Has history of retinal detachment or treatment or surgery for retinal detachment in the study eye
- Has history of a full thickness macular hole in the study eye
- Had any intraocular or periocular surgery within 3 months of Baseline Visit
- Has uncontrolled glaucoma in the study eye
- Had prior trabeculectomy or other filtration surgery in the study eye
- Has active intraocular inflammation or periocular infection in either eye
- Has current or history of scleromalacia in either eye
- Has aphakia or pseudophakia with absence of posterior capsule
- Has previous therapeutic radiation in the region of the study eye
- Has history of corneal transplant or corneal dystrophy in the study eye
- Has concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of safety, tolerability, or efficacy
- Has systolic blood pressure ≥160 mmHg and/or a diastolic blood pressure ≥95 mmHg at Screening
- Has an estimated Glomerular Filtration Rate (eGFR) of < 15 mL/min/1.73 m^2 as per the creatinine equation (CKD-EPI) at Screening
- Has any history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- Is a women who is pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Abilene, Texas, 79606
Study site
Arcadia, California, 91007
Study site
Austin, Texas, 78705
Study site
Baltimore, Maryland, 21237
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02114
Study site
Fort Myers, Florida, 33912
Study site
Omaha, Nebraska, 68105
Study site
Palm Desert, California, 92260
Study site
Phoenix, Arizona, 85014
Study site
San Antonio, Texas, 78240
Study site
Silverdale, Washington, 98383
About this study
Official title: Phase I Dose Escalation and Expansion Study of DS-7080a in Subjects With Neovascular Age-related Macular Degeneration or Diabetic Macular Edema
The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants.
In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose.
Read more
In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).
In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57.
Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.
- Being tested
- DS-7080a, Ranibizumab
- Keywords
- DS-7080a Monoclonal Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-7080aDrug
Also called Investigational product
1.0, 2.0, or 4.0 mg administered by a 50 μL intravitreal (IVT) injection of solution
RanibizumabDrug
Also called Lucentis
0.3 mg or 0.5 mg administered by a 50 μL IVT injection of solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1 DS-7080a dose escalation | Experimental | 3 sequential ascending dose levels (1.0, 2.0, 4.0 mg), every 4 weeks for 12 weeks Receives: Drug: DS-7080a |
| Part 2 DS-7080a | Experimental | Specific dose (either the maximum tolerated dose or 4.0 mg) of DS-7080a determined in Part 1, every 4 weeks for 12 weeks Receives: Drug: DS-7080a |
| Part 2 ranibizumab | Active comparator | Ranibizumab 0.5 mg, every 4 weeks for 12 weeks Receives: Drug: Ranibizumab |
| Part 2 DS-7080a and ranibizumab | Experimental | Specific dose of DS-7080a determined in Part 1 and ranibizumab 0.5 mg, every 4 weeks for 12 weeks Receives: Drug: DS-7080a; Drug: Ranibizumab |
| Part 3 DS-7080a | Experimental | Specific dose of DS-7080a determined in Part 1, every 4 weeks for 12 weeks Receives: Drug: DS-7080a |
| Part 3 ranibizumab | Experimental | Ranibizumab 0.3 mg, every 4 weeks for 12 weeks Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing any treatment-emergent adverse event (TEAE)
Treatment-emergent AEs (TEAEs) are defined as those adverse events (AEs) that were new or got worse between the start of study treatment and the end of the follow-up period.
Measured: 16 weeks
Best Corrected Visual Acuity (BCVA) score
Visual acuity of both eyes will be assessed at all study visits using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. Added to the score for the last row where the participant could read all five letters correctly are scores for each additional letter that could be read correctly in the next row. This is the BCVA score. A higher score means better visual acuity (sharpness of vision).
Measured: 12 weeks
Secondary outcomes (4)
Change from baseline in retinal thickness and volume
Retinal thickness and volume are assessed by spectral domain optical coherence tomography (SD-OCT)
Measured: 12 weeks
Change from baseline in retinal leakage
Retinal leakage is assessed by fluorescein angiography (FA)
Measured: 12 weeks
Plasma concentrations
Concentration of study drug in blood plasma
Measured: 12 weeks
Part 3 only: Change from baseline in vessel flow density, foveal avascular zone (FAZ) area, and FAZ shape
Vessel flow density, foveal avascular zone (FAZ) area, and FAZ shape are assessed by OCT angiography (OCT-A)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Model description
- Sequential Assignment with 3 cohorts in Part 1, Parallel Assignment with 3 arms in Part 2, and Parallel Assignment with 2 arms in Part 3
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530918
- Sponsor's protocol ID
- DS7080-A-U101
- Status last verified
- May 2018
- First submitted
- 17 Aug 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Publications
Afridi R, Senaldi G, Hwang JJ, Nguyen N, Inoue T, Berger B, Patel S, Fazal ZZ, Nguyen QD, Sepah Y. Assessing the Safety and Efficacy of Agonistic Monoclonal Antibody against Robo4 versus Ranibizumab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Phase I, Open-Label, Multicenter Study. Ophthalmol Sci. 2026 Jan 21;6(5):101084. doi: 10.1016/j.xops.2026.101084. eCollection 2026 May.
PubMed 42064470
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation and Expansion Study of DS-7080a in Subjects With Neovascular Age-related Macular Degeneration or Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02530918
- Acronym / sponsor ID
- DS7080-A-U101
- Keywords
- DS-7080a Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 21 Aug 2015 (estimated)
- 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.
The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants.
In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose.
In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a).
In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57.
Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential Assignment with 3 cohorts in Part 1, Parallel Assignment with 3 arms in Part 2, and Parallel Assignment with 2 arms in Part 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 DS-7080a dose escalation | Experimental | Drug: DS-7080a3 sequential ascending dose levels (1.0, 2.0, 4.0 mg), every 4 weeks for 12 weeks |
| Part 2 DS-7080a | Experimental | Drug: DS-7080aSpecific dose (either the maximum tolerated dose or 4.0 mg) of DS-7080a determined in Part 1, every 4 weeks for 12 weeks |
| Part 2 ranibizumab | Active comparator | Drug: RanibizumabRanibizumab 0.5 mg, every 4 weeks for 12 weeks |
| Part 2 DS-7080a and ranibizumab | Experimental | Drug: DS-7080a, Drug: RanibizumabSpecific dose of DS-7080a determined in Part 1 and ranibizumab 0.5 mg, every 4 weeks for 12 weeks |
| Part 3 DS-7080a | Experimental | Drug: DS-7080aSpecific dose of DS-7080a determined in Part 1, every 4 weeks for 12 weeks |
| Part 3 ranibizumab | Experimental | Drug: RanibizumabRanibizumab 0.3 mg, every 4 weeks for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 50 years of age
- Has active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD)
- CNV ≥ 50% of total lesion size in study eye
- Central sub-field thickness > 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye
- Has BCVA letter score required at screening visit:
Key exclusion criteria (49 listed)
- Has used any long acting steroids, either systemically or intraocularly, within 6 months of Baseline Visit
- Has total lesion size > 12 disc areas (30.5 mm2) in the study eye
- Has presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- Has history of any vitreous hemorrhage within 4 weeks prior to Screening Visit in the study eye
- Has presence of causes of CNV other than AMD
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 |
|---|---|---|
| DS-7080aAlso: Investigational product1.0, 2.0, or 4.0 mg administered by a 50 μL intravitreal (IVT) injection of solution | Drug | Part 1 DS-7080a dose escalation, Part 2 DS-7080a, Part 2 DS-7080a and ranibizumab, Part 3 DS-7080a |
| RanibizumabAlso: Lucentis0.3 mg or 0.5 mg administered by a 50 μL IVT injection of solution | Drug | Part 2 DS-7080a and ranibizumab, Part 2 ranibizumab, Part 3 ranibizumab |
Primary outcome
Number of participants experiencing any treatment-emergent adverse event (TEAE)
Time frame: 16 weeks
Treatment-emergent AEs (TEAEs) are defined as those adverse events (AEs) that were new or got worse between the start of study treatment and the end of the follow-up period.
Best Corrected Visual Acuity (BCVA) score
Time frame: 12 weeks
Visual acuity of both eyes will be assessed at all study visits using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. Added to the score for the last row where the participant could read all five letters correctly are scores for each additional letter that could be read correctly in the next row. This is the BCVA score. A higher score means better visual acuity (sharpness of vision).
4 secondary outcomes
Change from baseline in retinal thickness and volume
Time frame: 12 weeks
Change from baseline in retinal leakage
Time frame: 12 weeks
Plasma concentrations
Time frame: 12 weeks
Part 3 only: Change from baseline in vessel flow density, foveal avascular zone (FAZ) area, and FAZ shape
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 42064470Afridi R, Senaldi G, Hwang JJ, Nguyen N, Inoue T, Berger B, Patel S, Fazal ZZ, Nguyen QD, Sepah Y. Assessing the Safety and Efficacy of Agonistic Monoclonal Antibody against Robo4 versus Ranibizumab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Phase I, Open-Label, Multicenter Study. Ophthalmol Sci. 2026 Jan 21;6(5):101084. doi: 10.1016/j.xops.2026.101084. eCollection 2026 May.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
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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.
Global Clinical Leader study director
Daiichi Sankyo
12 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 DS-7080a and Ranibizumab in people with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema, run by Daiichi Sankyo at 12 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 12 inclusion and 49 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: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants experiencing any treatment-emergent adverse event (TEAE) (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530918, which also lists 1 linked publication.
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 9 May 2018.