Macular DegenerationPhase 1/2NCT00395707
Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
A Phase 1/2 study testing Lucentis, Ranibizumab and Ranibizumab (Lucentis) in people with Macular Degeneration, run by The National Retina Institute at 2 sites in United States.
Trial summary
The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Lucentis, Ranibizumab and Ranibizumab (Lucentis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Apr 2008
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 50 years
- Definite characteristic signs of age related macular degeneration including drusen
- Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)
Who cannot join
- Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
- Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
- Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Retina Institute
Chevy Chase, Maryland, 20815
National Retina Institute
Towson, Maryland, 21204
About this study
Official title: Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations
The primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
Read the detailed description
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
- Conditions
- Macular Degeneration
- Being tested
- Lucentis, Ranibizumab, Ranibizumab (Lucentis)
- Keywords
- Macular Degeneration, Age Related Macular Degeneration, Retinal Angiomatous Proliferations
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisDrug
Also called Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
RanibizumabDrug
Also called Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab (Lucentis)Drug
Also called Ranibizumab, Lucentis
0.3mg/0.05 ml intravitreally
Ranibizumab (Lucentis)Drug
Also called Ranibizumab, Lucentis
0.5mg/0.05 ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lucentis 0.3mg/0.05 ml Receives: Drug: Lucentis; Drug: Ranibizumab; Drug: Ranibizumab (Lucentis) |
| 2 | Active comparator | Lucentis 0.5mg/0.05 ml Receives: Drug: Lucentis; Drug: Ranibizumab; Drug: Ranibizumab (Lucentis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Measured: 2 years
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Measured: 12 months
Incidence and severity of ocular adverse events
Measured: 12 months
Incidence and severity of non-ocular adverse events
Measured: 12 months
Changes in vital signs
Measured: 12 months
Secondary outcomes (6)
Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
Measured: 12 months
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
Measured: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
Measured: 2 years
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses
Measured: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG
Measured: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startAug 2005
- Primary completionApr 2008
- Study completionApr 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Thomas M Johnson, MD, Principal investigator, National Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395707
- Sponsor's protocol ID
- FVF3423s
- Status last verified
- Feb 2009
- First submitted
- 1 Nov 2006
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations
- ClinicalTrials.gov ID
- NCT00395707
- Acronym / sponsor ID
- FVF3423s
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration, Age Related Macular Degeneration, Retinal Angiomatous Proliferations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The National Retina InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Nov 2006 (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 primary objective of this study is to determine the safety \& efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
Detailed description
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lucentis, Drug: Ranibizumab, Drug: Ranibizumab (Lucentis)Lucentis 0.3mg/0.05 ml |
| 2 | Active comparator | Drug: Lucentis, Drug: Ranibizumab, Drug: Ranibizumab (Lucentis)Lucentis 0.5mg/0.05 ml |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 50 years
- Definite characteristic signs of age related macular degeneration including drusen
- Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)
Key exclusion criteria (7 listed)
- Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
- Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
- Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
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 |
|---|---|---|
| LucentisAlso: Ranibizumab0.3mg/0.05 ml or 0.5mg/0.05 ml | Drug | 1, 2 |
| RanibizumabAlso: Lucentis0.3mg/0.05 ml or 0.5mg/0.05 ml | Drug | 1, 2 |
| Ranibizumab (Lucentis)Also: Ranibizumab, Lucentis0.3mg/0.05 ml intravitreally | Drug | 1 |
| Ranibizumab (Lucentis)Also: Ranibizumab, Lucentis0.5mg/0.05 ml | Drug | 2 |
Primary outcome
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Time frame: 2 years
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Time frame: 12 months
Incidence and severity of ocular adverse events
Time frame: 12 months
Incidence and severity of non-ocular adverse events
Time frame: 12 months
Changes in vital signs
Time frame: 12 months
6 secondary outcomes
Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions
Time frame: 12 months
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography
Time frame: 2 years
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG
Time frame: 2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination
Time frame: 2 years
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 Feb 2009.
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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.
Thomas M Johnson, MD principal investigator
National Retina Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lucentis, Ranibizumab and Ranibizumab (Lucentis) in people with Macular Degeneration, run by The National Retina Institute at 2 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 4 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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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?
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters (time frame: 2 years). The study lists 5 primary outcomes in all. 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 9 Feb 2009.