Age-related Macular DegenerationPhase 1/2PROTECTNCT02302989
Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration
A Phase 1/2 study testing Ranibizumab 0.5mg in people with Age-related Macular Degeneration, run by Leonard Feiner, MD, PhD at 2 sites in United States.
Trial summary
To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Ranibizumab 0.5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 50 years old
- Able to sign informed consent and comply with the study protocol for the duration of the two years.
- Nonexudative age-related macular degeneration (AMD) in one eye (study eye) •At time of enrollment, fellow non-study eye must have recently diagnosed (not more than 2 years prior to enrollment), angiographically documented, previously untreated prior to diagnosis, CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.
Who cannot join
- Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal Avastin®, intravitreal Eylea®, thermal laser, external beam radiation or other AMD therapy in the study eye.
- History of macular hole in study eye.
- History of vitrectomy in study eye.
- Lens extraction or implantation within the last 3 months.
- Capsulotomy within the last 1 month.
- Lens or other media opacity that would preclude good fundus photography or angiography within the next 2 years.
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- Nevus > 2 disc areas within 3000 microns of the foveal center or with fluid or leakage on fluorescein angiography.
- Macular edema or signs of diabetic retinopathy more severe than 10 red dots (microaneurysms or blot hemorrhages).
- Retinal changes related to high myopia and no myopic correction greater than 8.00 diopters spherical equivalent [sphere + ½ cylinder].
- Any progressive ocular disease that would affect visual acuity within the next 2 years.
- Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment.
- Concurrent use of systemic anti-VEGF agents.
- Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 25 mmHg) despite treatment with antiglaucoma medication).
- Patients who are unable to be photographed to document CNV due to known allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV.
- Patients with other ocular diseases that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy.
- Current treatment for active systemic infection.
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders.
- History of recurrent significant infections or bacterial infections.
- Inability to comply with study or follow-up procedures.
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NJ Retina (Retina Associates of New Jersey)
Teaneck, New Jersey, 07666
NJ Retina (Retina Associates of New Jersey)
Vauxhall, New Jersey, 07088
About this study
Official title: Prospective Double-blind Randomized Study to Evaluate Lucentis for Prophylaxis Against the Conversion to Neovascular Age-related Macular Degeneration (AMD) in High-risk Eyes (Let's ProTECT AMD Eyes)
To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration
Read the detailed description
This is an open-label, prospective, randomized study of intravitreally administered ranibizumab 0.5 mg in subjects with unilateral neovascular AMD in which the fellow (study) eye is at high-risk for also developing conversion to neovascular AMD.
The Study will determine the efficacy of a quarterly injection of Ranibizumab to prevent the conversion of dry age-related macular degeneration to neovascular AMD in high risk eyes.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Ranibizumab 0.5mg
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5mgDrug
Also called Lucentis
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | No treatment. Observation only |
| Quarterly Ranibizumab 0.5 | Active comparator | Quarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg Receives: Drug: Ranibizumab 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT)
The development of CNV will be assessed by CNV leakage on FA and evidence of any fluid on SD-OCT.
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 posted27 Nov 2014 (estimated)
- Study startMay 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonard Feiner, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- NJ Retina (Retina Associates of New Jersey)
- Responsible party
- Sponsor-investigator, Leonard Feiner, MD, PhD, NJ Retina (Retina Associates of New Jersey)
- Investigators
- Leonard Feiner, MD, MD, PhD, Principal investigator, NJ Retina (Retina Associates of New Jersey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302989
- Sponsor's protocol ID
- ML29346
- Acronym
- PROTECT
- Status last verified
- Aug 2018
- First submitted
- 25 Nov 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double-blind Randomized Study to Evaluate Lucentis for Prophylaxis Against the Conversion to Neovascular Age-related Macular Degeneration (AMD) in High-risk Eyes (Let's ProTECT AMD Eyes)
- ClinicalTrials.gov ID
- NCT02302989
- Acronym / sponsor ID
- PROTECT / ML29346
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Leonard Feiner, MD, PhDUniversity, hospital or other
- Collaborators
- NJ Retina (Retina Associates of New Jersey)
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Nov 2014 (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.
To evaluate Ranibizumab as prophylaxis against the conversion to neovascular Age-Related Macular Degeneration
Detailed description
This is an open-label, prospective, randomized study of intravitreally administered ranibizumab 0.5 mg in subjects with unilateral neovascular AMD in which the fellow (study) eye is at high-risk for also developing conversion to neovascular AMD.
The Study will determine the efficacy of a quarterly injection of Ranibizumab to prevent the conversion of dry age-related macular degeneration to neovascular AMD in high risk eyes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –No treatment. Observation only |
| Quarterly Ranibizumab 0.5 | Active comparator | Drug: Ranibizumab 0.5mgQuarterly intravitreal injection of 0.5mg Ranibizumab Intervention: Drug: Ranibizumab 0.5mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 50 years old
- Able to sign informed consent and comply with the study protocol for the duration of the two years.
- Nonexudative age-related macular degeneration (AMD) in one eye (study eye) •At time of enrollment, fellow non-study eye must have recently diagnosed (not more than 2 years prior to enrollment), angiographically documented, previously untreated prior to diagnosis, CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.
Key exclusion criteria (25 listed)
- Previous treatment with verteporfin PDT, Macugen®, Lucentis®, intravitreal Avastin®, intravitreal Eylea®, thermal laser, external beam radiation or other AMD therapy in the study eye.
- History of macular hole in study eye.
- History of vitrectomy in study eye.
- Lens extraction or implantation within the last 3 months.
- Capsulotomy within the last 1 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 |
|---|---|---|
| Ranibizumab 0.5mgAlso: Lucentis | Drug | Quarterly Ranibizumab 0.5 |
Primary outcome
Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT)
Time frame: 2 years
The development of CNV will be assessed by CNV leakage on FA and evidence of any fluid on SD-OCT.
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 28 Aug 2018.
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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.
Leonard Feiner, MD, MD, PhD principal investigator
NJ Retina (Retina Associates of New Jersey)
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 Ranibizumab 0.5mg in people with Age-related Macular Degeneration, run by Leonard Feiner, MD, PhD 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 3 inclusion and 25 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 28 Aug 2018. 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?
Conversion to neovascular AMD. (CNV leakage on FA and evidence of any fluid on SD-OCT) (time frame: 2 years). 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 28 Aug 2018.