Pigment Epithelial DetachmentPhase 2NCT00841581
Lucentis to Treat Pigment Epithelial Detachment
A Phase 2 study testing Ranibizumab in people with Pigment Epithelial Detachment, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pigment Epithelial Detachment
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Dec 2011
- 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
- Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
- PED under the geometric center of the foveal avascular zone.
- Evidence of recent disease progression as suggested by one or more of the following: sub-retinal lipid or cystic macular edema, sub-retinal hemorrhage, vision loss within the last 3 months or documented lesion growth on FA over previous 6 months.
- Visual acuity of between 20/40 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 meters.
- Ambulatory Vision in the fellow eye
- Willingness and ability to participate and provide written informed consent.
Who cannot join
- Individuals with choroidal neovascularization from causes other than AMD.
- Patients physically unable to tolerate intravenous fluorescein angiography
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
- Individuals with physical or mental disabilities that prevent accurate vision testing.
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- History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
- Prior photodynamic therapy for CNV.
- Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- Women of childbearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Lucentis (iL) (Ranibizumab) for the Treatment of AMD Related Pigment Epithelial Detachment (PED)
Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation.
Read the detailed description
Background:
Exudative Age Related Macular Degeneration (AMD) results in a significant and severe visual loss if left untreated as documented in natural history and observational arms of studies such as the macular photocoagulation study (MPS) and the Tap and VIP study with Visudyne. It is also clear however, that the different lesion types (classified by intravenous fluorescein angiography ((IVFA)) as occult, minimally classic or predominately classic) have both a different natural history and a different response to treatment.
The recent introduction of the anti-VEGF agents such as Macugen and Lucentis have significantly advanced our ability to treat AMD as both agents show clear efficacy across all lesion subtypes regardless of lesion composition.
A clear absence of literature on clinical outcomes exist however for fibrovascular pigment epithelial detachments (PED). PED represents a form of exudative AMD which clearly behaves in a unique and distinctive manner when compared to the lesion(s) described above.
As standard exclusion criteria within most of the major AMD trials, lesion composition of any IVFA subtype is acceptable as long as less then 50% of the lesion is composed of blood or pigment epithelial detachment. This has resulted in a notable absence of clinical literature on the response of predominately PED type lesions to current standard of care anti-VEGF agents. In an effort to address this absence, a prospective evaluation of the response of predominately PED type lesions to Lucentis, the current gold standard therapy is needed.
Study design:
Thirty two patients will be recruited to participate based on the Inclusion / Exclusion Criteria described in a later paragraph.
Patients will receive monthly intravitreal Lucentis injections every 33 days (+/- 4 days) for 6 months. At 6 months, patients will be evaluated based on ETDRS Visual Acuity and OCT to determine response to Lucentis therapy. Patients not experiencing a visual improvement from baseline ETDRS acuity (defined as a net gain from baseline of 10 or more letters) or showing a reduction in the height of the fibrovascular PED lesion on OCT of greater than 30% from baseline OCT will be deemed Lucentis non-responders. These patients will receive no further intravitreal Lucentis injections, but will undergo re-evaluation at 12 months.
Patients deemed responders, will continue with an OCT-guided 6 months active treatment period. In these patients, iL will be administered if evidence of visual loss of 1 or more lines (Snellen) from 6-month visit values, evidence of intraretinal or subretinal fluid on OCT, or growth of PED by greater than 50 microns from the 6-month visit OCT values.
Non-responders will be evaluated only at the 12-month final visit.
Baseline IVFA, OCT, Snellen Visual Acuity, ETDRS refraction and contrast sensitivity will be obtained along with a comprehensive ophthalmological examination. Complete diagnostic assessments including fluorescein angiography, OCT and visual function testing will be repeated at 3, 6 and 12 months after baseline treatment. In addition, patients who will continue on active intravitreal Lucentis therapy beyond 6 months (responders), will undergo monthly OCT examinations (months 6 through 11) and ophthalmic safety examinations in order to determine the need for Lucentis administration.
At the final, Month 12 visit, all patients will undergo ophthalmic examination, OCT, ETDRS refraction, Snellen Visual Acuity and contrast sensitivity.
- Conditions
- Pigment Epithelial Detachment
- Being tested
- Ranibizumab
- Keywords
- Age Related Macular Degeneration, Pigment Epithelial Detachment, Intravitreal Detachment, Anti-VEGF
- Medical subject headings
- Retinal Detachment, 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, DIN 02296810
Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Lucentis | Experimental | All patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart.
Measured: 6 months
Secondary outcomes (5)
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.
Measured: 6 months
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity.
Measured: 6 months
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).
Measured: 6 months
To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.
Measured: 12 months
To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigment Epithelial DetachmentStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Thomas G. Sheidow, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Thomas G Sheidow, MD, Principal investigator, Ivey Eye Institute, LOndon, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841581
- Sponsor's protocol ID
- R-08-410
- Other IDs
- 15392
- Status last verified
- Dec 2011
- First submitted
- 9 Feb 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Lucentis (iL) (Ranibizumab) for the Treatment of AMD Related Pigment Epithelial Detachment (PED)
- ClinicalTrials.gov ID
- NCT00841581
- Acronym / sponsor ID
- R-08-410
- Conditions
- Pigment Epithelial Detachment
- Keywords
- Age Related Macular Degeneration, Pigment Epithelial Detachment, Intravitreal Detachment, Anti-VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Feb 2009 (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 Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation.
Detailed description
Background:
Exudative Age Related Macular Degeneration (AMD) results in a significant and severe visual loss if left untreated as documented in natural history and observational arms of studies such as the macular photocoagulation study (MPS) and the Tap and VIP study with Visudyne. It is also clear however, that the different lesion types (classified by intravenous fluorescein angiography ((IVFA)) as occult, minimally classic or predominately classic) have both a different natural history and a different response to treatment.
The recent introduction of the anti-VEGF agents such as Macugen and Lucentis have significantly advanced our ability to treat AMD as both agents show clear efficacy across all lesion subtypes regardless of lesion composition.
A clear absence of literature on clinical outcomes exist however for fibrovascular pigment epithelial detachments (PED). PED represents a form of exudative AMD which clearly behaves in a unique and distinctive manner when compared to the lesion(s) described above.
As standard exclusion criteria within most of the major AMD trials, lesion composition of any IVFA subtype is acceptable as long as less then 50% of the lesion is composed of blood or pigment epithelial detachment. This has resulted in a notable absence of clinical literature on the response of predominately PED type lesions to current standard of care anti-VEGF agents. In an effort to address this absence, a prospective evaluation of the response of predominately PED type lesions to Lucentis, the current gold standard therapy is needed.
Study design:
Thirty two patients will be recruited to participate based on the Inclusion / Exclusion Criteria described in a later paragraph.
Patients will receive monthly intravitreal Lucentis injections every 33 days (+/- 4 days) for 6 months. At 6 months, patients will be evaluated based on ETDRS Visual Acuity and OCT to determine response to Lucentis therapy. Patients not experiencing a visual improvement from baseline ETDRS acuity (defined as a net gain from baseline of 10 or more letters) or showing a reduction in the height of the fibrovascular PED lesion on OCT of greater than 30% from baseline OCT will be deemed Lucentis non-responders. These patients will receive no further intravitreal Lucentis injections, but will undergo re-evaluation at 12 months.
Patients deemed responders, will continue with an OCT-guided 6 months active treatment period. In these patients, iL will be administered if evidence of visual loss of 1 or more lines (Snellen) from 6-month visit values, evidence of intraretinal or subretinal fluid on OCT, or growth of PED by greater than 50 microns from the 6-month visit OCT values.
Non-responders will be evaluated only at the 12-month final visit.
Baseline IVFA, OCT, Snellen Visual Acuity, ETDRS refraction and contrast sensitivity will be obtained along with a comprehensive ophthalmological examination. Complete diagnostic assessments including fluorescein angiography, OCT and visual function testing will be repeated at 3, 6 and 12 months after baseline treatment. In addition, patients who will continue on active intravitreal Lucentis therapy beyond 6 months (responders), will undergo monthly OCT examinations (months 6 through 11) and ophthalmic safety examinations in order to determine the need for Lucentis administration.
At the final, Month 12 visit, all patients will undergo ophthalmic examination, OCT, ETDRS refraction, Snellen Visual Acuity and contrast sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lucentis | Experimental | Drug: RanibizumabAll patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
- PED under the geometric center of the foveal avascular zone.
- Evidence of recent disease progression as suggested by one or more of the following: sub-retinal lipid or cystic macular edema, sub-retinal hemorrhage, vision loss within the last 3 months or documented lesion growth on FA over previous 6 months.
- Visual acuity of between 20/40 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 meters.
- Ambulatory Vision in the fellow eye
Key exclusion criteria (10 listed)
- Individuals with choroidal neovascularization from causes other than AMD.
- Patients physically unable to tolerate intravenous fluorescein angiography
- Any intraocular surgery within 2 months in the study eye.
- Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
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, DIN 02296810Ranibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months. | Drug | Lucentis |
Primary outcome
To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart.
Time frame: 6 months
5 secondary outcomes
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.
Time frame: 6 months
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity.
Time frame: 6 months
To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).
Time frame: 6 months
To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.
Time frame: 12 months
To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).
Time frame: 12 months
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 8 Dec 2011.
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 G Sheidow, MD principal investigator
Ivey Eye Institute, LOndon, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab in people with Pigment Epithelial Detachment, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 10 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 8 Dec 2011. 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 Canada. 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?
To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart. (time frame: 6 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 8 Dec 2011.