Myopic Choroidal Neovascular MembraneINGECTNCT01218230
Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
A study testing Intravitreal Pegaptanib in people with Myopic Choroidal Neovascular Membrane, run by L.V. Prasad Eye Institute at 1 site in India.
Trial summary
Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopic Choroidal Neovascular Membrane
- What is being tested?
- Intravitreal Pegaptanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2010to Jul 2012
- Phase
- Interventional
- 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
- Should be willing to participate in the trial.
- Age less than 55 years.
- Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
- Myopia of ≥ 6 Diopters.
- Fluorescein angiographic documentation of CNV.
Who cannot join
- Ocular causes, or other ocular disorders leading to vision loss.
- Maculopathy not related to pathologic myopia.
- Pregnancy, lactation.
- Not willing to provide an informed consent.
- History of previous macular laser including PDT.
- Other forms of therapy including intravitreal injections.
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- History of intraocular surgery in the past 3 months.
- Anticipated cataract surgery in the next 6 months.
- Any active infection or inflammation in the eye.
- Cases where good quality imaging is not possible, either due to hazy media or extremely high myopia.
- Patients with uncontrolled glaucoma, with IOP > 21mm Hg on 2 or more medications.
- Patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size.
- Eyes with previous retinal detachment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia
Read the detailed description
This is a Prospective Interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. After taking an informed consent, the patients will be given intravitreal Pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. Thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). Final assessment will be done at 54 weeks and all the baseline investigations will be performed.
- Conditions
- Myopic Choroidal Neovascular Membrane
- Being tested
- Intravitreal Pegaptanib
- Keywords
- Pegaptanib, myopic CNVM, intravitreal anti-VEGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal PegaptanibDrug
Also called Macugen
Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Pegaptanib | Active comparator | Not described Receives: Drug: Intravitreal Pegaptanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
Measured: 12 months
Secondary outcomes (1)
Mean change in macular thickness on OCT from baseline to 54 weeks
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 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: Funding did not come through as the product was sold to another company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic Choroidal Neovascular MembraneStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Raja Narayanan, L.V. Prasad Eye Institute
- Investigators
- Raja Narayanan, MD, Principal investigator, LV Prasad Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218230
- Sponsor's protocol ID
- LEC08205
- Acronym
- INGECT
- Status last verified
- Sep 2015
- First submitted
- 8 Oct 2010
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Study the Efficacy and Safety of Intravitreal Pegaptanib in Treatment of Choroidal Neovascularisation Secondary to Pathologic Myopia
- ClinicalTrials.gov ID
- NCT01218230
- Acronym / sponsor ID
- INGECT / LEC08205
- Conditions
- Myopic Choroidal Neovascular Membrane
- Keywords
- Pegaptanib, myopic CNVM, intravitreal anti-VEGF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding did not come through as the product was sold to another company.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 11 Oct 2010 (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.
Intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia
Detailed description
This is a Prospective Interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. After taking an informed consent, the patients will be given intravitreal Pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. Thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). Final assessment will be done at 54 weeks and all the baseline investigations will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Pegaptanib | Active comparator | Drug: Intravitreal Pegaptanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Should be willing to participate in the trial.
- Age less than 55 years.
- Best corrected visual acuity (BCVA) score of at least 5 letters (20/200), as assessed by ETDRS chart.
- Myopia of ≥ 6 Diopters.
- Fluorescein angiographic documentation of CNV.
Key exclusion criteria (13 listed)
- Ocular causes, or other ocular disorders leading to vision loss.
- Maculopathy not related to pathologic myopia.
- Pregnancy, lactation.
- Not willing to provide an informed consent.
- History of previous macular laser including PDT.
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 |
|---|---|---|
| Intravitreal PegaptanibAlso: MacugenIntravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN. | Drug | Intravitreal Pegaptanib |
Primary outcome
Visual Acuity
Time frame: 12 months
Mean change in visual acuity from baseline to 54 weeks as measured by ETDRS chart
1 secondary outcome
Mean change in macular thickness on OCT from baseline to 54 weeks
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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.
Raja Narayanan, MD principal investigator
LV Prasad Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Pegaptanib in people with Myopic Choroidal Neovascular Membrane, run by L.V. Prasad Eye Institute at 1 site in India.
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: withdrawn, as of the sponsor's last update on 2 Sep 2015. 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 India. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual Acuity (time frame: 12 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 2 Sep 2015.