Macular DegenerationPhase 2NCT00259753
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
A Phase 2 study testing Bevasiranib in people with Macular Degeneration, run by OPKO Health, Inc. at 23 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Bevasiranib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 23 sitesUnited States
- Study dates
- Jul 2005to Dec 2007
- Phase
- Phase 2
- 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
- Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
- Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
- Patients must be age 50 or older
Who cannot join
- Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
- Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
- Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
- Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
- Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
- Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
- Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Sall Research Medical Center
Artesia, California, 90701
Retina Reseach Center
Austin, Texas, 78705
Retina Associates of Cleveland
Beachwood, Ohio, 44122
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Southeast Clinical Research
Charlotte, North Carolina, 28210
VitreoRetinal Surgery, P.A.
Edina, Minnesota, 55435
Ophthalmology Associates
Fort Worth, Texas, 76102
Vitreo-Retinal Associates PC
Grand Rapids, Michigan, 49525
Associated Retinal Consultants
Grand Rapids, Michigan, 49546
Vitreoretinal Consultants Houston TX
Houston, Texas, 77030
Eye Foundation of Kansas City, UMKC School of Medicine
Kansas City, Missouri, 64108
Retina-Vitreous Center
Lakewood, New Jersey, 08701
Retina Associates of Cleveland, Inc.
Lakewood, Ohio, 44107
Retina-Vitreous Consultants
Livingston, New Jersey, 07039
OCLI
Lynbrook, New York, 11563
Medical College of Wisconsin Eye Institute
Milwaukee, Wisconsin, 53226
LuEsther T. Mertz Retinal Research Center
New York, New York, 10021
Acuity Participating Site
Phoenix, Arizona, 85014
Black Hills Eye Institute
Rapid City, South Dakota, 57701
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
Retina Specialist
Towson, Maryland, 21204
Retina Centers PC
Tucson, Arizona, 85704
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.
- Conditions
- Macular Degeneration
- Being tested
- Bevasiranib
- Keywords
- Wet Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevasiranibDrug
Also called Cand5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.2 mg/eye Receives: Drug: Bevasiranib |
| 2 | Experimental | 1.5 mg/eye Receives: Drug: Bevasiranib |
| 3 | Experimental | 3.0 mg/eye Receives: Drug: Bevasiranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Measured: 12 week
Secondary outcomes (1)
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Denis O'Shaughnessy, PHD, Study director, Opko Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259753
- Sponsor's protocol ID
- ACU201
- Status last verified
- Jul 2008
- First submitted
- 30 Nov 2005
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00259753
- Acronym / sponsor ID
- ACU201
- Conditions
- Macular Degeneration
- Keywords
- Wet Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Dec 2005 (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 objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bevasiranib0.2 mg/eye |
| 2 | Experimental | Drug: Bevasiranib1.5 mg/eye |
| 3 | Experimental | Drug: Bevasiranib3.0 mg/eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
- Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
- Patients must be age 50 or older
Key exclusion criteria (7 listed)
- Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
- Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
- Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
- Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
- Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
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 |
|---|---|---|
| BevasiranibAlso: Cand5 | Drug | 1, 2, 3 |
Primary outcome
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Time frame: 12 week
1 secondary outcome
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
Time frame: 12 week
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 5 Aug 2008.
- SponsorLink provided by the sponsor.
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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.
Denis O'Shaughnessy, PHD study director
Opko Health
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevasiranib in people with Macular Degeneration, run by OPKO Health, Inc. at 23 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 3 inclusion and 7 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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography. (time frame: 12 week). 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 5 Aug 2008.