Age-Related Macular DegenerationPhase 1NCT01271270
Palomid 529 in Patients With Neovascular Age-Related Macular Degeneration
A Phase 1 study testing Palomid 529 in people with Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in the back of the eye, and leak blood and other fluids that damage the eye, produce scarring, and lead to blindness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Palomid 529
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2010to 20 Sep 2012
- 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
- Participant must be 18 years of age or older.
- Participant must understand and sign the protocol s informed consent document.
- Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
- Women of childbearing potential must agree to use reliable methods of contraception during the study period and for three months following the last injection. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or partner with vasectomy).
Who cannot join
- Participant is actively receiving another investigational study therapy. Participation in NIH protocol 08-EI-0103, High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal Ranibizumab Injection for Neovascular Age-Related Macular Degeneration is allowed, if s/he has been enrolled for at least one year, as this is an imaging study providing standard-of-care ranibizumab.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has evidence of ocular disease other than neovascular AMD in the study eye that may confound the outcome of the study (i.e., diabetic macular edema, myopic choroidal neovascularization or uveitic macular edema).
- Participant has evidence of retinal pigment epithelial detachment (unless subretinal or intraretinal fluid is present)in the study eye.
- Participant received an anti-VEGF injection in the study eye within 12 days prior to enrollment.
- Participant received or has been receiving intraocular steroids in the study eye within four months prior to enrollment.
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- Participant received or has been receiving immunosuppressive treatments (i.e., biologic or systemic steroids) within two months prior to enrollment. If the participant was on any systemic immunosuppressive treatment for at least two months prior to enrollment and meets the enrollment criteria of residual fluid after four serial anti-VEGF injections, then s/he is eligible to participate in the study as long as s/he will continue this specific systemic drug regimen for the entire study period.
- Participant is allergic to fluorescein dye or indocyanine green dye.
- Participant is allergic to shellfish or iodine.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Unmasked Study to Investigate the Safety and Tolerability of Subconjunctival Injections of Palomid 529 in Patients With Neovascular Age-Related Macular Degeneration
Background:
- Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in the back of the eye, and leak blood and other fluids that damage the eye, produce scarring, and lead to blindness. People diagnosed with wet AMD have increased production of a body chemical called vascular endothelial growth factor (VEGF). VEGF is important in the formation of blood vessels in the body, and decreasing the production of VEGF is believed to help wet AMD patients by preventing or slowing the growth of the abnormal blood vessels. Anti-VEGF drugs have been used to decrease the production of VEGF, but some people do not respond completely to these drugs.
- A protein in the body called mTOR also plays a critical role in regulating how cells divide and grow and obtain their blood supply. The experimental chemical Palomid 529 inhibits the production of mTOR. Researchers are interested in determining whether Palomid 529 is safe and can help individuals with wet AMD who have not completely responded to anti-VEGF treatments.
Read more
Objectives:
- To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related macular degeneration in individuals who have not responded to standard anti-VEGF treatments.
Eligibility:
- Individuals with wet age-related macular degeneration in at least one eye that has not responded to standard anti-VEGF treatments.
Design:
- Prior to the first visit, participants should have been seen at the National Eye Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103, High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be designated as the study eye to receive the Palomid 529 treatment.
- Participants will have a full physical examination and medical history, a full eye examination to evaluate eye health and vision, angiography to examine the blood vessels in the eyes, and blood and urine tests during the study
- Participants will receive an injection of Palomid 529 into the study eye every 4 weeks during the study, for a total of three injections. Participants may also receive anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the study eye 12 days before and 12 days after the Palomid 529 injection.
- Participants may have standard-of-care treatments for the non-study eye if it has wet AMD as well, but may not receive experimental treatments in the non-study eye while they are in this study.
- Participants will return for long-term follow-up examinations as directed by the study researchers.
Read the detailed description
Objective:
Paloma Pharmaceuticals, Inc. has developed a non-steroidal, wholly synthetic, small molecule drug for application to diseases of aberrant neovasculature, known as Palomid 529.1 Palomid 529 exerts broad activity as an anti-angiogenic agent by inhibiting the mammalian target of rapamycin (Akt/mTor) signal transduction pathway via dissociation of both target of rapamycin complexes (TORC1 and TORC2) in the immune system.
The objective of this study is to evaluate the safety and tolerability of Palomid 529 when administered as subconjunctival injections in participants with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (AMD).
Study Population:
This study will enroll participants with neovascular AMD who have not responded to conventional anti-VEGF treatments. Five participants will be initially accrued; however, up to seven participants who meet the eligibility criteria may be enrolled.
Design:
This is a 12-week, unmasked, non-randomized study of three serial 1.9 mg subconjunctival doses of Palomid 529 in neovascular AMD participants who have not responded to conventional anti-VEGF treatments.
Outcome Measures:
The primary outcome is to determine the safety of subconjunctival Palomid 529 for neovascular AMD. Safety outcomes include the number and severity of ocular and systemic adverse events. Secondary efficacy outcomes include changes in best-corrected visual acuity (BCVA), changes in fluid status, central retinal thickness and retinal volume as measured by optical coherence tomography (OCT), changes in leakage patterns as observed on fluorescein angiography (FA), changes in CNV patterns as observed on indocyanine green angiography (ICG), changes in autofluorescence patterns as observed on fundus autofluorescence (FAF) imaging, and changes in fundus appearance as observed on color fundus photography. Additionally, Complement Factor H polymorphisms will be compared with treatment response and pharmacokinetic samples will be collected.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Palomid 529
- Keywords
- Age-Related Macular Degeneration (AMD), Palomid 529, Age Related Macular Degeneration, AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palomid 529Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to determine the safety of subconjunctival Palomid 539 neovascular AMD. Safety outcomes include the number and severity of ocular and systemic adverse events.
Secondary outcomes (1)
Efficacy outcomes include changes in BCVA, fluid status, central retinal thickness, retinal volume, leakage patterns, CNV patterns and fundus appearance. Collecting Complement Factor H Genotypes and pharmacokinetic samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study start20 Dec 2010
- Primary completion20 Sep 2012
- Study completion20 Sep 2012
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Catherine Meyerle, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271270
- Sponsor's protocol ID
- 110066
- Other IDs
- 11-EI-0066
- Status last verified
- 20 Sep 2012
- First submitted
- 5 Jan 2011
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Dalal M, Jacobs-El N, Nicholson B, Tuo J, Chew E, Chan CC, Nussenblatt R, Ferris F, Meyerle C. Subconjunctival Palomid 529 in the treatment of neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2705-9. doi: 10.1007/s00417-013-2375-7. Epub 2013 May 21.
PubMed 23689994
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Unmasked Study to Investigate the Safety and Tolerability of Subconjunctival Injections of Palomid 529 in Patients With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01271270
- Acronym / sponsor ID
- 110066
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration (AMD), Palomid 529, Age Related Macular Degeneration, AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 20 Dec 2010
- Primary completion
- 20 Sep 2012 (actual)
- Study completion
- 20 Sep 2012 (actual)
- First posted
- 6 Jan 2011 (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.
Background:
- Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in the back of the eye, and leak blood and other fluids that damage the eye, produce scarring, and lead to blindness. People diagnosed with wet AMD have increased production of a body chemical called vascular endothelial growth factor (VEGF). VEGF is important in the formation of blood vessels in the body, and decreasing the production of VEGF is believed to help wet AMD patients by preventing or slowing the growth of the abnormal blood vessels. Anti-VEGF drugs have been used to decrease the production of VEGF, but some people do not respond completely to these drugs.
- A protein in the body called mTOR also plays a critical role in regulating how cells divide and grow and obtain their blood supply. The experimental chemical Palomid 529 inhibits the production of mTOR. Researchers are interested in determining whether Palomid 529 is safe and can help individuals with wet AMD who have not completely responded to anti-VEGF treatments.
Objectives:
- To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related macular degeneration in individuals who have not responded to standard anti-VEGF treatments.
Eligibility:
- Individuals with wet age-related macular degeneration in at least one eye that has not responded to standard anti-VEGF treatments.
Design:
- Prior to the first visit, participants should have been seen at the National Eye Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103, High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be designated as the study eye to receive the Palomid 529 treatment.
- Participants will have a full physical examination and medical history, a full eye examination to evaluate eye health and vision, angiography to examine the blood vessels in the eyes, and blood and urine tests during the study
- Participants will receive an injection of Palomid 529 into the study eye every 4 weeks during the study, for a total of three injections. Participants may also receive anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the study eye 12 days before and 12 days after the Palomid 529 injection.
- Participants may have standard-of-care treatments for the non-study eye if it has wet AMD as well, but may not receive experimental treatments in the non-study eye while they are in this study.
- Participants will return for long-term follow-up examinations as directed by the study researchers.
Detailed description
Objective:
Paloma Pharmaceuticals, Inc. has developed a non-steroidal, wholly synthetic, small molecule drug for application to diseases of aberrant neovasculature, known as Palomid 529.1 Palomid 529 exerts broad activity as an anti-angiogenic agent by inhibiting the mammalian target of rapamycin (Akt/mTor) signal transduction pathway via dissociation of both target of rapamycin complexes (TORC1 and TORC2) in the immune system.
The objective of this study is to evaluate the safety and tolerability of Palomid 529 when administered as subconjunctival injections in participants with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (AMD).
Study Population:
This study will enroll participants with neovascular AMD who have not responded to conventional anti-VEGF treatments. Five participants will be initially accrued; however, up to seven participants who meet the eligibility criteria may be enrolled.
Design:
This is a 12-week, unmasked, non-randomized study of three serial 1.9 mg subconjunctival doses of Palomid 529 in neovascular AMD participants who have not responded to conventional anti-VEGF treatments.
Outcome Measures:
The primary outcome is to determine the safety of subconjunctival Palomid 529 for neovascular AMD. Safety outcomes include the number and severity of ocular and systemic adverse events. Secondary efficacy outcomes include changes in best-corrected visual acuity (BCVA), changes in fluid status, central retinal thickness and retinal volume as measured by optical coherence tomography (OCT), changes in leakage patterns as observed on fluorescein angiography (FA), changes in CNV patterns as observed on indocyanine green angiography (ICG), changes in autofluorescence patterns as observed on fundus autofluorescence (FAF) imaging, and changes in fundus appearance as observed on color fundus photography. Additionally, Complement Factor H polymorphisms will be compared with treatment response and pharmacokinetic samples will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be 18 years of age or older.
- Participant must understand and sign the protocol s informed consent document.
- Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
- Women of childbearing potential must agree to use reliable methods of contraception during the study period and for three months following the last injection. Acceptable methods of contraception include hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or partner with vasectomy).
Key exclusion criteria (9 listed)
- Participant is actively receiving another investigational study therapy. Participation in NIH protocol 08-EI-0103, High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal Ranibizumab Injection for Neovascular Age-Related Macular Degeneration is allowed, if s/he has been enrolled for at least one year, as this is an imaging study providing standard-of-care ranibizumab.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has evidence of ocular disease other than neovascular AMD in the study eye that may confound the outcome of the study (i.e., diabetic macular edema, myopic choroidal neovascularization or uveitic macular edema).
- Participant has evidence of retinal pigment epithelial detachment (unless subretinal or intraretinal fluid is present)in the study eye.
- Participant received an anti-VEGF injection in the study eye within 12 days prior to enrollment.
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 |
|---|---|---|
| Palomid 529 | Drug | – |
Primary outcome
The primary outcome is to determine the safety of subconjunctival Palomid 539 neovascular AMD. Safety outcomes include the number and severity of ocular and systemic adverse events.
1 secondary outcome
Efficacy outcomes include changes in BCVA, fluid status, central retinal thickness, retinal volume, leakage patterns, CNV patterns and fundus appearance. Collecting Complement Factor H Genotypes and pharmacokinetic samples.
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 Jul 2018.
- Derived from this study: PubMed 23689994Dalal M, Jacobs-El N, Nicholson B, Tuo J, Chew E, Chan CC, Nussenblatt R, Ferris F, Meyerle C. Subconjunctival Palomid 529 in the treatment of neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2705-9. doi: 10.1007/s00417-013-2375-7. Epub 2013 May 21.
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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.
Catherine Meyerle, M.D. principal investigator
National Eye Institute (NEI)
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 Palomid 529 in people with Age-Related Macular Degeneration, run by National Eye Institute (NEI) 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 4 inclusion and 9 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 Jul 2018. 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?
The primary outcome is to determine the safety of subconjunctival Palomid 539 neovascular AMD. Safety outcomes include the number and severity of ocular and systemic adverse events.. 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 NCT01271270, 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 5 Jul 2018.