Retinal Pigment Epithelial DetachmentPhase 1NCT00749021
Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments
A Phase 1 study testing Ranibizumab in people with Retinal Pigment Epithelial Detachment, run by Clement K. Chan at 3 sites in United States.
Trial summary
This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Retinal Pigment Epithelial Detachment
- 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
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Aug 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 50 years or older
- Patient is willing to participate in this study and to follow the criteria and protocol of this study.
- Patient is not involved with another clinical trial.
- Ability to understand the informed consent and willingness to sign the consent.
- Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
- PED less than or equal to 12 disc area in size
Show all 12Show fewer
- BCVA with ETDRS of greater than or equal to 19 letters and less than or equal to 69 letters (20/400 to 20/40)
- Central 1-mm foveal thickness of greater than or equal to 250 microns on OCT.
- Greatest linear diameter of the submacular hemorrhage needs to be less than 50% of the entire PED.
- Submacular fibrosis needs to be less than 50% of the entire PED.
- Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA, and FP.
- Intraocular pressure of 25 mm or less in the study eye, with or without use of ocular hypotensive agents.
Who cannot join
- Pregnancy or lactation
- Premenopausal women not using adequate contraception
- Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
- Contraindication to pupillary dilation in study eye
- Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requirements
- Presence of any advanced systemic condition or endstage disease, advanced Alzheimer syndrome, endstage cancer, etc., which will likely prevent patient from completing study.
Show all 21Show fewer
- Previous therapeutic radiation in the region of the study eye.
- Prior anti-vascular endothelial factor therapy within 30 days.
- More than 3 sessions of prior anti-VEGF therapy.
- More than 1 prior photodynamic therapy (PDT)
- Prior triamcinolone in the past 6 months or dexamethasone in the past 1 month.
- Prior retinal pigment epithelial (RPE) tear in study eye.
- Prior ocular surgery (except YAG laser capsulotomy) for study eye within past 90 days.
- Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.
- Prior therapy for AMD (except minerals and vitamins), including laser, within the past 30 days.
- Prior intraocular or periocular corticosteroid therapy within the past 120 days
- Prior vitrectomy
- Presence of any causes of CNV and PED other than due to AMD.
- Presence of any substantial ocular disease (other than CNV and PED) that may compromise vision in the study eye and/or confound interpretation of the date; e.g. substantial cataracts, concomitant diabetic retinopathy affecting the macula, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- Presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, angioid streaks, pathologic myopia (spherical equivalent of greater than or equal to -8 diopters of myopia or axial length of greater than or equal to 25 mm), choroidal rupture, multifocal choroiditis, etc.
- Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening or Day 0.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jules Stein Eye Institute
Los Angeles, California, 90095
Southern California Desert Retina Consultants
Palm Desert, California, 92211
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
About this study
Official title: A Phase I Study to Evaluate the Efficacy and Safety of Treating Subfoveal Pigment Epithelial Detachment Associated With Choroidal Neovascularization With Anti-vascular Endothelial Growth Factor Fragment, Ranibizumab.
This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.
- Conditions
- Retinal Pigment Epithelial Detachment
- Being tested
- Ranibizumab
- Keywords
- choroidal neovascularization, vascularized
- Medical subject headings
- Retinal Detachment, Choroidal Neovascularization, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
0.5 mg of intravitreal ranibizumab monthly for 12 months
RanibizumabDrug
Also called Lucentis
0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
RanibizumabDrug
Also called Lucentis
2.0mg of intravitreal ranibizumab monthly for 12 months
RanibizumabDrug
Also called Lucentis
2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Active comparator | Intravitreal injection of Ranibizumab monthly for 12 months. Receives: Drug: Ranibizumab |
| Regimen 2 | Active comparator | Intravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria. Receives: Drug: Ranibizumab |
| Regimen 3 | Active comparator | Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months Receives: Drug: Ranibizumab |
| Regimen 4 | Active comparator | Intravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.
Measured: 12 months
Secondary outcomes (10)
Proportion of eyes reaching BCVA greater than or equal to 20/200
Measured: 12 months
Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart
Measured: 12 months
Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT
Measured: 12 months
Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline
Measured: 12 months
Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline
Measured: 12 months
Status of fluorescein staining or leakage (increased or decreased) from baseline
Measured: 12 months
Ocular safety outcome including ocular complication, i.e. RPE tears, uveitis, endophthalmitis
Measured: 12 months
Systemic safety outcome including cardiovascular event, cerebral vascular events
Measured: 12 months
Proportion of patients with an improvement from baseline in Contrast Sensitivity at 24 and 48 weeks
Measured: 24 and 48 weeks
Proportion of patients with an improvement from baseline in the VFQ overall composite score and near and distance activities subscales at 24 and 48 weeks
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 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 Retinal Pigment Epithelial DetachmentStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clement K. Chan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clement K. Chan, Southern California Desert Retina Consultants, MC
- Investigators
- Clement K Chan, M.D., Principal investigator, Southern California Desert Retina Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749021
- Sponsor's protocol ID
- FVF4332s
- Status last verified
- Oct 2012
- First submitted
- 8 Sep 2008
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.
PubMed 25277305
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Efficacy and Safety of Treating Subfoveal Pigment Epithelial Detachment Associated With Choroidal Neovascularization With Anti-vascular Endothelial Growth Factor Fragment, Ranibizumab.
- ClinicalTrials.gov ID
- NCT00749021
- Acronym / sponsor ID
- FVF4332s
- Conditions
- Retinal Pigment Epithelial Detachment
- Keywords
- choroidal neovascularization, vascularized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clement K. ChanUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Sep 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.
This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Active comparator | Drug: RanibizumabIntravitreal injection of Ranibizumab monthly for 12 months. |
| Regimen 2 | Active comparator | Drug: RanibizumabIntravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria. |
| Regimen 3 | Active comparator | Drug: RanibizumabIntravitreal injection of Ranibizumab 2.0mg monthly for 12 months |
| Regimen 4 | Active comparator | Drug: RanibizumabIntravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient is 50 years or older
- Patient is willing to participate in this study and to follow the criteria and protocol of this study.
- Patient is not involved with another clinical trial.
- Ability to understand the informed consent and willingness to sign the consent.
- Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
Key exclusion criteria (21 listed)
- Pregnancy or lactation
- Premenopausal women not using adequate contraception
- Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
- Contraindication to pupillary dilation in study eye
- Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requirements
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: Lucentis0.5 mg of intravitreal ranibizumab monthly for 12 months | Drug | Regimen 1 |
| RanibizumabAlso: Lucentis0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing | Drug | Regimen 2 |
| RanibizumabAlso: Lucentis2.0mg of intravitreal ranibizumab monthly for 12 months | Drug | Regimen 3 |
| RanibizumabAlso: Lucentis2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing | Drug | Regimen 4 |
Primary outcome
Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months.
Time frame: 12 months
10 secondary outcomes
Proportion of eyes reaching BCVA greater than or equal to 20/200
Time frame: 12 months
Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart
Time frame: 12 months
Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT
Time frame: 12 months
Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline
Time frame: 12 months
Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline
Time frame: 12 months
Status of fluorescein staining or leakage (increased or decreased) from baseline
Time frame: 12 months
Ocular safety outcome including ocular complication, i.e. RPE tears, uveitis, endophthalmitis
Time frame: 12 months
Systemic safety outcome including cardiovascular event, cerebral vascular events
Time frame: 12 months
Proportion of patients with an improvement from baseline in Contrast Sensitivity at 24 and 48 weeks
Time frame: 24 and 48 weeks
Proportion of patients with an improvement from baseline in the VFQ overall composite score and near and distance activities subscales at 24 and 48 weeks
Time frame: 24 and 48 weeks
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 Oct 2012.
- Derived from this study: PubMed 25277305Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3.
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.
Clement K Chan, M.D. principal investigator
Southern California Desert Retina Consultants
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranibizumab in people with Retinal Pigment Epithelial Detachment, run by Clement K. Chan at 3 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 12 inclusion and 21 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 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 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 NCT00749021, 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 Oct 2012.