Macular EdemaPhase 1NCT02403128
Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
A Phase 1 study testing aflibercept in people with Macular Edema and Retinal Artery Macroaneurysm, run by Kamal Kishore, MD at 1 site in United States.
Trial summary
Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Retinal Artery Macroaneurysm
- What is being tested?
- aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2015to Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic macular edema caused by RAM in one of the eyes. If both eyes are involved, the eye with worse central foveal thickness will be enrolled in the study.
- CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
- Best-corrected visual acuity of 73 to 24 letters.
- Willing and able to comply with clinic visits and study-related procedures.
- Willing to provide informed consent -
Who cannot join
- Media opacity
- pre-retinal fibrosis, retinal detachment, vitreo-macular traction
- Infectious keratitis, conjunctivitis, blepharitis or scleritis
- Any ocular surgery during the preceding 3 months.
- aphakia or uncontrolled glaucoma
- subfoveal hemorrhage
Show all 13Show fewer
- History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
- Any other ocular disease responsible for decrease in vision.
- Concomitant ocular disease that can cause increase in foveal thickness
- Ocular inflammation from any cause
- Recent (<3 months) history of a thromboembolic event
- Pregnant or breast feeding women.
- Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Retina and Eye Associates
Peoria, Illinois, 61615
About this study
Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.
Read the detailed description
Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity, complete eye exam, including IOP measurement, color photos and intravenous fluorescein angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit, best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits.
Retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. CFT >310 microns 2. Intraretinal or subretinal fluid on SDOCT 3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color photographs.
Final follow-up will be at six months. Data collected will include, change in ETDRS visual acuity from the baseline, change in CFT, number of injections, number of eyes completely dry by SDOCT, and number of eyes with a thrombosed RAM by IVFA.
- Conditions
- Macular Edema, Retinal Artery Macroaneurysm
- Being tested
- aflibercept
- Keywords
- 362.17
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptDrug
Also called Eylea
Intravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients with macular edema from RAM | Experimental | Intravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection. Receives: Drug: aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept
Measured: six months
Secondary outcomes (5)
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Measured: six months.
Change in central field macular thickness at 3 and 6 months
Measured: six months
Proportion of eyes completely dry by spectral domain OCT
Measured: six months
Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
Measured: six months
Number of patients requiring additional treatment beyond baseline and total number of treatments
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start14 May 2015
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamal Kishore, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kamal Kishore, MD, Illinois Retina and Eye Associates
- Investigators
- Kamal Kishore, MD, Principal investigator, Illinois Retina and Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403128
- Sponsor's protocol ID
- Kishore_Eylea_RAM
- Status last verified
- Aug 2019
- First submitted
- 23 Mar 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
- ClinicalTrials.gov ID
- NCT02403128
- Acronym / sponsor ID
- Kishore_Eylea_RAM
- Conditions
- Macular Edema, Retinal Artery Macroaneurysm
- Keywords
- 362.17
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kamal Kishore, MDUniversity, hospital or other
- Study start
- 14 May 2015 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 31 Mar 2015 (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.
Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.
Detailed description
Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity, complete eye exam, including IOP measurement, color photos and intravenous fluorescein angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit, best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits.
Retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. CFT >310 microns 2. Intraretinal or subretinal fluid on SDOCT 3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color photographs.
Final follow-up will be at six months. Data collected will include, change in ETDRS visual acuity from the baseline, change in CFT, number of injections, number of eyes completely dry by SDOCT, and number of eyes with a thrombosed RAM by IVFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with macular edema from RAM | Experimental | Drug: afliberceptIntravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic macular edema caused by RAM in one of the eyes. If both eyes are involved, the eye with worse central foveal thickness will be enrolled in the study.
- CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
- Best-corrected visual acuity of 73 to 24 letters.
- Willing and able to comply with clinic visits and study-related procedures.
- Willing to provide informed consent -
Key exclusion criteria (13 listed)
- Media opacity
- pre-retinal fibrosis, retinal detachment, vitreo-macular traction
- Infectious keratitis, conjunctivitis, blepharitis or scleritis
- Any ocular surgery during the preceding 3 months.
- aphakia or uncontrolled glaucoma
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 |
|---|---|---|
| afliberceptAlso: EyleaIntravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol. | Drug | Patients with macular edema from RAM |
Primary outcome
Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept
Time frame: six months
5 secondary outcomes
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Time frame: six months.
Change in central field macular thickness at 3 and 6 months
Time frame: six months
Proportion of eyes completely dry by spectral domain OCT
Time frame: six months
Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
Time frame: six months
Number of patients requiring additional treatment beyond baseline and total number of treatments
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
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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.
Kamal Kishore, MD principal investigator
Illinois Retina and Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aflibercept in people with Macular Edema and Retinal Artery Macroaneurysm, run by Kamal Kishore, MD 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 13 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: status not confirmed, as of the sponsor's last update on 8 Aug 2019. 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 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?
Results are not available in the source record.
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?
Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept (time frame: six 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 Aug 2019.