Dry Age-Related Macular DegenerationPhase 1NCT00950638
A Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
A Phase 1 study testing Avacincaptad Pegol in people with Dry Age-Related Macular Degeneration, run by Ophthotech Corporation at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-Related Macular Degeneration
- What is being tested?
- Avacincaptad Pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2009to 24 Mar 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dry AMD (drusen and/or geographic atrophy) in both eyes
Who cannot join
- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.
- History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- Any of the following underlying diseases including:
- Diabetic retinopathy
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV ), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
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- History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- Clinically significant impaired renal (serum creatinine >2.5 mg/dl or status post renal transplant or receiving dialysis) or hepatic function. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
- Women who are pregnant or nursing. Known serious allergies to the fluorescein dye used in angiography or to the components of the ARC1905 formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Establish the Safety and Tolerability of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
- Conditions
- Dry Age-Related Macular Degeneration
- Being tested
- Avacincaptad Pegol
- Keywords
- AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avacincaptad PegolDrug
Also called Zimura (previous name), IZERVAY, ARC1905
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| dose comparison | Active comparator | Not described Receives: Drug: Avacincaptad Pegol |
| Dose comparison | Active comparator | Not described Receives: Drug: Avacincaptad Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study start16 Jul 2009
- Primary completion24 Mar 2011
- Study completion24 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950638
- Sponsor's protocol ID
- OPH2001
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2009
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Establish the Safety and Tolerability of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00950638
- Acronym / sponsor ID
- OPH2001
- Conditions
- Dry Age-Related Macular Degeneration
- Keywords
- AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2009 (actual)
- Primary completion
- 24 Mar 2011 (actual)
- Study completion
- 24 Mar 2011 (actual)
- First posted
- 3 Aug 2009 (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 objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose comparison | Active comparator | Drug: Avacincaptad Pegol |
| Dose comparison | Active comparator | Drug: Avacincaptad Pegol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dry AMD (drusen and/or geographic atrophy) in both eyes
Key exclusion criteria (11 listed)
- Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.
- History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- Diabetic retinopathy
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV ), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
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 |
|---|---|---|
| Avacincaptad PegolAlso: Zimura (previous name), IZERVAY, ARC1905intravitreal injection | Drug | Dose comparison, dose comparison |
Primary outcome
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
Time frame: 1 year
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 10 Mar 2025.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avacincaptad Pegol in people with Dry Age-Related Macular Degeneration, run by Ophthotech Corporation at 1 site 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 1 inclusion and 11 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes (time frame: 1 year). 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 10 Mar 2025.