Age-related Macular DegenerationPhase 2/3DETAILNCT00590694
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
A Phase 2/3 study testing ranibizumab in people with Age-related Macular Degeneration and Pigment Epithelial Detachment, run by Pacific Eye Associates at 1 site in United States.
Trial summary
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2009
- Phase
- Phase 2/3
- 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
- Neovascular age-related macular degeneration patients over age 50
- Presence of a pigment epithelial detachment on optical coherence tomography
- Initial or recurrent disease
- Previous treatment allowed
- Visual acuity between Snellen 20/40 - 20/400
Who cannot join
- More than three previous treatments with PDT or other radiation/laser therapy
- Previous vitrectomy or other AMD surgical intervention
- Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)
- Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Eye Associates
San Francisco, California, 94115
About this study
Official title: Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
- Conditions
- Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration, Wet Macular Degeneration
- Being tested
- ranibizumab
- Keywords
- ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO
- Medical subject headings
- Macular Degeneration, Retinal Detachment, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis injection
0.5mg injection monthly according to protocol for one year
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Active comparator | Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs. Receives: Drug: ranibizumab |
| Group 2 | Active comparator | Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur. Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual acuity from baseline over 12 months
Measured: 12 months
Secondary outcomes (3)
Time to OCT resolution of macular edema and pigment epithelial detachment
Measured: One year
Proportion of patients with complete resolution of PED at 6 and 12 months
Measured: 12 months
Durability of outcome: time from last ranibizumab injection to retreatment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2009
- Study completionDec 2009
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Anne Fung, MD, Principal investigator, Pacific Eye Associates / California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590694
- Sponsor's protocol ID
- DETAIL Study for PED in AMD
- Acronym
- DETAIL
- Status last verified
- Apr 2012
- First submitted
- 26 Dec 2007
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.
PubMed 17386270
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
- ClinicalTrials.gov ID
- NCT00590694
- Acronym / sponsor ID
- DETAIL / DETAIL Study for PED in AMD
- Conditions
- Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration, Wet Macular Degeneration
- Keywords
- ranibizumab, Lucentis, Pigment Epithelial Detachment, Macular Degeneration, PrONTO
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pacific Eye AssociatesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 2008 (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.
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Active comparator | Drug: ranibizumabWill receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs. |
| Group 2 | Active comparator | Drug: ranibizumabWill receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neovascular age-related macular degeneration patients over age 50
- Presence of a pigment epithelial detachment on optical coherence tomography
- Initial or recurrent disease
- Previous treatment allowed
- Visual acuity between Snellen 20/40 - 20/400
Key exclusion criteria (4 listed)
- More than three previous treatments with PDT or other radiation/laser therapy
- Previous vitrectomy or other AMD surgical intervention
- Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)
- Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
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 |
|---|---|---|
| ranibizumabAlso: Lucentis injection0.5mg injection monthly according to protocol for one year | Drug | Group 2, Group1 |
Primary outcome
Mean change in visual acuity from baseline over 12 months
Time frame: 12 months
3 secondary outcomes
Time to OCT resolution of macular edema and pigment epithelial detachment
Time frame: One year
Proportion of patients with complete resolution of PED at 6 and 12 months
Time frame: 12 months
Durability of outcome: time from last ranibizumab injection to retreatment
Time frame: One 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 12 Apr 2012.
- Background: PubMed 17386270Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.
- Pacific Eye Associates websiteLink 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.
Anne Fung, MD principal investigator
Pacific Eye Associates / California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ranibizumab in people with Age-related Macular Degeneration and Pigment Epithelial Detachment, run by Pacific Eye Associates 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 5 inclusion and 4 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 12 Apr 2012. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean change in visual acuity from baseline over 12 months (time frame: 12 months). 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 NCT00590694, 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 12 Apr 2012.