Age Related Macular DegenerationPhase 1NCT00446654
Safety of 16.5 mg (3.3%) CGC-11047 Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to AMD
A Phase 1 study testing CGC-11047 in people with Age Related Macular Degeneration, run by Progen Pharmaceuticals at 8 sites in 3 countries.
Trial summary
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- CGC-11047
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Apr 2007to Oct 2007
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with a diagnosis of subfoveal choroidal neovascularization secondary to AMD in the study eye, with leaking present on a fluorescein angiogram as determined by the clinical investigator.
- Visual acuity: BCVA in the study eye between 20/40 and 20/320 and better than or equal to 20/320 in the fellow eye.
- Patients who refuse standard of care or have not benefited from standard of care in the opinion of the principal investigator.
- Clear ocular media and adequate pupillary dilatation to permit good quality ophthalmologic exam.
- Male or female patients aged >= 50 years.
- Ability to understand and the willingness to sign a written informed consent document and return for all study visits.
Who cannot join
- Patients with CNV not due to AMD in the study eye.
- Patients with a retinal tear in the study eye.
- Patient has a subretinal hemorrhage that comprises more than 50% of total lesion size, or has atrophy or fibrosis in the center of fovea.
- Patients who have undergone intraocular surgery within 2 months or extrafoveal/juxtafoveal laser within 3 months of study entry in the study eye.
- Any macular disease other than AMD causing vision loss in either eye.
- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. Anterior segment diseases such as blepharitis, ocular rosacea, lid problems which could increase the risk of infection after study drug injection.
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- Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg (P0) on maximum medical therapy) or clinically significant glaucomatous visual field loss in both eyes.
- Significant media opacities, including cataract that might interfere with visual acuity, assessment of toxicities or fundus photography in the study eye in the judgement of the clinical investigator.
- Spherical refractive error more than -8.0 diopters in the study eye.
- Use of any approved or investigational AMD agent (standard of care) within four weeks of study enrollment.
- Use of any systemic investigational agent within 30 days of study enrollment.
- Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a clinically significant or symptomatic cardiac arrhythmia, recent myocardial infarction (within 6 months), or evidence of a current significant ventricular conduction abnormality.
- Women who are pregnant or breast-feeding.
- Women of childbearing potential and male patients who are partners of women of childbearing potential who are unwilling to use approved, effective means of contraception according to the institution's standards.
- Allergy to fluorescein dye.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Russia6 sites
Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development
Cheboksary
Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development
Moscow
Closed Joint Stock Company "Inter YuNA"
Rostov-on-Don
Federal State Establishment "Intersectoral Research and Technology Complex "Eye Microsurgery" named by Academic SN Fyodorov of Federal Agency for Healthcare and Social Development
Saint Petersburg
Saint Petersburg State Healthcare Establishment "City Consultative Diagnostic Centre #1"
Saint Petersburg
State Educational Establishment of Higher Professional Education "Military Medical Academy named by SM Kirov"
Saint Petersburg
About this study
Official title: A Phase Ib Randomized Open Label Study Between Once-every-two-weeks and Once-every-four-weeks Treatment of CGC-11047 in Patients With CNV Due to Age Related Macular Degeneration
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals.
Read the detailed description
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. Half of the participants in the study will receive CGC-11047 every two weeks and half of the participants in the study will receive CGC-11047 every four weeks. If your doctor determines that you are eligible for the study based on his/her judgement and according to the entry requirements set by the sponsor of the research, you will be randomly assigned (by chance, like the flip of a coin), to receive CGC-11047 every two weeks or every four weeks. Whether you receive drug every two weeks or every four weeks, you will still need to come to the clinic approximately every two weeks for the first three months, and approximately four times after that until it has been at least 12 months since you received your first treatment of study drug.
Two studies (this one and another one) are occurring to test CGC-11047 in patients with wet age-related macular degeneration for the first time. However, this drug (CGC-11047) is being studied in cancer patients at doses much higher than will be given to any subjects in either of these studies. The cancer patients have tolerated the drug well with the exception of one cancer patient who had two reactions to the drug (pancreatitis and hypotension). However, this patient had advanced cancer (non-Hodgkin's lymphoma with a life expectancy of less than 3 months) and received 38X the dose to be administered in this AMD study. Aside from this one patient, there have not been any serious side effects related to the drug.
This study will involve about 100 subjects at about 15 different sites internationally.
The study will take place over 12 months and will include about 12 office visits to the study doctor.
- Conditions
- Age Related Macular Degeneration
- Being tested
- CGC-11047
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGC-11047Drug
Also called PG11047
16.5 mg (3.3%) subconjunctival injection
| Study group | Role | What they receive |
|---|---|---|
| CGC-11047 once every 2 weeks | Experimental | 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. Receives: Drug: CGC-11047 |
| CGC-11047 once every four weeks | Experimental | 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. Receives: Drug: CGC-11047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline to 3 Months in Best Corrected Visual Acuity
Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).
The outcome measure presented is the difference in LogMAR between baseline and at three months.
Measured: Baseline and 3 months
Secondary outcomes (2)
Safety of 2-weekly or 4-weekly Administration of CGC-11047
Measured: 3 months
To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Progen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Campochiaro, MD, Principal investigator, Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446654
- Sponsor's protocol ID
- 47-MD-002
- Status last verified
- Jun 2012
- First submitted
- 9 Mar 2007
- Last updated
- 6 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Randomized Open Label Study Between Once-every-two-weeks and Once-every-four-weeks Treatment of CGC-11047 in Patients With CNV Due to Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00446654
- Acronym / sponsor ID
- 47-MD-002
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Progen PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Posted 6 Aug 2012
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 research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals.
Detailed description
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. Half of the participants in the study will receive CGC-11047 every two weeks and half of the participants in the study will receive CGC-11047 every four weeks. If your doctor determines that you are eligible for the study based on his/her judgement and according to the entry requirements set by the sponsor of the research, you will be randomly assigned (by chance, like the flip of a coin), to receive CGC-11047 every two weeks or every four weeks. Whether you receive drug every two weeks or every four weeks, you will still need to come to the clinic approximately every two weeks for the first three months, and approximately four times after that until it has been at least 12 months since you received your first treatment of study drug.
Two studies (this one and another one) are occurring to test CGC-11047 in patients with wet age-related macular degeneration for the first time. However, this drug (CGC-11047) is being studied in cancer patients at doses much higher than will be given to any subjects in either of these studies. The cancer patients have tolerated the drug well with the exception of one cancer patient who had two reactions to the drug (pancreatitis and hypotension). However, this patient had advanced cancer (non-Hodgkin's lymphoma with a life expectancy of less than 3 months) and received 38X the dose to be administered in this AMD study. Aside from this one patient, there have not been any serious side effects related to the drug.
This study will involve about 100 subjects at about 15 different sites internationally.
The study will take place over 12 months and will include about 12 office visits to the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGC-11047 once every 2 weeks | Experimental | Drug: CGC-1104716.5 mg CGC-11047 as a subconjunctival injection once every two weeks. |
| CGC-11047 once every four weeks | Experimental | Drug: CGC-1104716.5 mg CGC-11047 as a subconjunctival injection once every four weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of subfoveal choroidal neovascularization secondary to AMD in the study eye, with leaking present on a fluorescein angiogram as determined by the clinical investigator.
- Visual acuity: BCVA in the study eye between 20/40 and 20/320 and better than or equal to 20/320 in the fellow eye.
- Patients who refuse standard of care or have not benefited from standard of care in the opinion of the principal investigator.
- Clear ocular media and adequate pupillary dilatation to permit good quality ophthalmologic exam.
- Male or female patients aged >= 50 years.
Key exclusion criteria (16 listed)
- Patients with CNV not due to AMD in the study eye.
- Patients with a retinal tear in the study eye.
- Patient has a subretinal hemorrhage that comprises more than 50% of total lesion size, or has atrophy or fibrosis in the center of fovea.
- Patients who have undergone intraocular surgery within 2 months or extrafoveal/juxtafoveal laser within 3 months of study entry in the study eye.
- Any macular disease other than AMD causing vision loss in either eye.
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 |
|---|---|---|
| CGC-11047Also: PG1104716.5 mg (3.3%) subconjunctival injection | Drug | CGC-11047 once every 2 weeks, CGC-11047 once every four weeks |
Primary outcome
Change in Baseline to 3 Months in Best Corrected Visual Acuity
Time frame: Baseline and 3 months
Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read). The outcome measure presented is the difference in LogMAR between baseline and at three months.
2 secondary outcomes
Safety of 2-weekly or 4-weekly Administration of CGC-11047
Time frame: 3 months
To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Campochiaro, MD principal investigator
Wilmer Eye Institute, Johns Hopkins Hospital School of Medicine
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGC-11047 in people with Age Related Macular Degeneration, run by Progen Pharmaceuticals at 8 sites in 3 countries.
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 6 inclusion and 16 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 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia, United States, Mexico. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Baseline to 3 Months in Best Corrected Visual Acuity (time frame: Baseline and 3 months). 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 6 Aug 2012.