Neovascular Age Related Macular DegenerationNCT01942213
Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients.
An observational study of Neovascular Age Related Macular Degeneration, run by Prism Vision Group at 1 site in United States.
Trial summary
This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Neovascular Age Related Macular Degeneration
- Type of treatment
- Injection or infusion
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2016
- Phase
- Observational
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Private practice patients referred to retinal specialist for treatment of Neovascular Age-Related Macular Degeneration
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 65-90 years
- Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Who cannot join
- Previous intraocular inflammation
- Treatment with systemic anti-inflammatory agents
- Known systemic autoimmune diseases
- Treatment with intraocular steroids in the past 3 months
- History of intraocular surgery in the past 3 months
- Age greater than 90 years
- Patients who were switched between either therapies in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients
This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.
Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.
Read the detailed description
Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study
- Age 65-90 years
- Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Exclusion Criteria:
- Previous intraocular inflammation
- Treatment with systemic anti-inflammatory agents
- Known systemic autoimmune diseases
- Treatment with intraocular steroids in the past 3 months
- History of intraocular surgery in the past 3 months
- Age greater than 90 years
- Patients who were switched between either therapies in the past 3 months
- Keywords
- Macular, Degeneration, Age related, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving Ranibizumab | 150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection. | |
| Subjects receiving Aflibercept | 150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.
All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4.
Measured: 2-3 days after injection
Secondary outcomes (1)
To evaluate patients 2-3 days post-injection for best corrected visual acuity
Best corrected visual acuity will be assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study eye chart at a starting test distance of 4 meters.
Measured: 2-3 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Vision Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Roth, MD, Principal investigator, Prism Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942213
- Sponsor's protocol ID
- NJRetina ML28942
- Other IDs
- NJRetina Observational ML28942
- Status last verified
- May 2016
- First submitted
- 10 Sep 2013
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients
- ClinicalTrials.gov ID
- NCT01942213
- Acronym / sponsor ID
- NJRetina ML28942
- Keywords
- Macular, Degeneration, Age related, Neovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Prism Vision GroupUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Sep 2013 (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 open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection.
Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection.
Detailed description
Patients, age 65 to 90, with Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept will be selected in this study. 300 subjects from one site in the United States will be enrolled.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study
- Age 65-90 years
- Diagnosis of Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Exclusion Criteria:
- Previous intraocular inflammation
- Treatment with systemic anti-inflammatory agents
- Known systemic autoimmune diseases
- Treatment with intraocular steroids in the past 3 months
- History of intraocular surgery in the past 3 months
- Age greater than 90 years
- Patients who were switched between either therapies in the past 3 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving Ranibizumab | – | –150 Subjects diagnosed with Neovascular Age-Related Macular Degeneration receiving Ranibizumab 0.5 mg administered by intravitreal injection. |
| Subjects receiving Aflibercept | – | –150 Subjects diagnosed with Age-related Macular Degeneration receiving Aflibercept 2 mg administered by intravitreal injection |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Private practice patients referred to retinal specialist for treatment of Neovascular Age-Related Macular Degeneration
Key inclusion criteria (3 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age 65-90 years
- Diagnosis or Neovascular Age-Related Macular Degeneration who present for treatment with intravitreal ranibizumab or aflibercept
Key exclusion criteria (7 listed)
- Previous intraocular inflammation
- Treatment with systemic anti-inflammatory agents
- Known systemic autoimmune diseases
- Treatment with intraocular steroids in the past 3 months
- History of intraocular surgery in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept.
Time frame: 2-3 days after injection
All eyes will be evaluated 2-3 days after injection and graded in terms of (a) aqueous cells, graded subjectively on a scale of 0-4, (b) aqueous flare, graded subjectively on a scale 0-4, (c) aqueous flare graded objectively with the FM-600 Kowa flare meter and (d) vitreous haze, graded subjectively on a scale of 0-4.
1 secondary outcome
To evaluate patients 2-3 days post-injection for best corrected visual acuity
Time frame: 2-3 days post-injection
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 1 Jun 2016.
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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.
Daniel Roth, MD principal investigator
Prism Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age Related Macular Degeneration, run by Prism Vision Group 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 3 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 1 Jun 2016. 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.
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 evaluate post-intravitreal injection inflammatory response in patients receiving either ranibizumab or aflibercept. (time frame: 2-3 days after injection). 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 1 Jun 2016.