Cystoid Macular EdemaPhase 1/2NCT00358423
The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema
A Phase 1/2 study testing Pegaptanib Sodium in people with Cystoid Macular Edema, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to look at the effects of an experimental drug called pegaptanib (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that can occur after cataract surgery. Swelling in the retina can lead to blurry vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- Pegaptanib Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (ages 18 years or older)
- Best corrected visual acuity < 20/40 but no worse than 20/800 in the study eye
- Best corrected visual acuity better than or equal to 20/200 in the fellow eye
- Post-surgical CME in the study eye as documented on OCT (central subfield >/= 250 microns)
- Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed.
- Initiation of pegaptanib or sham injections may begin following at least 12 weeks of topical therapy for CME after cataract surgery or the other eye,if the best-corrected visual acuity has not improved by at least 5 letters and if the center point thickening on OCT has not improved by at least 20%. Patients who have been on topical ketorolac for greater than 12 weeks are still eligible for this study.
Who cannot join
- History of intravitreal steroid (triamcinolone) injection into the study eye or fellow eye within 4 months prior to cataract surgery
- CME due to other etiologies such as vein occlusion and diabetes.
- Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Pilot Study of the Effect of Pegaptanib Sodium in Patients With Chronic, Post-Operative Cystoid Macular Edema
This research is being done to look at the effects of an experimental drug called pegaptanib (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that can occur after cataract surgery. Swelling in the retina can lead to blurry vision.
The only treatment available for this condition is eye drops that decrease swelling in the back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after cataract surgery.
Read the detailed description
While only 1% to 2% of people following cataract surgery develop visual acuity loss from chronic post-surgical cystoid macular edema (CME), this represents approximately 20,000 individuals in the U.S. each year, and many more throughout the world. No current drug or surgical treatment is very effective in the management of chronic post-surgical CME. Topical non-steroidal anti-inflammatory medications, such as ketorolac drops 4 times a day (qid) for 3 months, have been shown to reduce the extent of fluorescein leakage on angiography in patients with this condition; however, compliance can be difficult, not all cases resolve following this treatment, the drop is not approved for this indication, and it is unknown if this treatment has an effect that lasts beyond 3 to 6 months. The fluorescein angiographic findings and the effects of ketorolac drops suggest that the condition is a result of increased permeability from inflammation and might resolve with a therapy that decreases abnormal vessel permeability. Recent studies have shown that vascular endothelial growth factor (VEGF) plays a major role in vessel permeability. Pegaptanib (Macugen) is an FDA-approved drug for wet AMD. Pegaptanib is a selective VEGF antagonist that blocks the effects of VEGF; therefore,pegaptanib may decrease vessel permeability and possibly decrease CME. Pegaptanib has been shown to have some activity in reducing retinal blood vessel leakage in diabetic patients with chronic macular edema (Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-57.), further supporting the hypothesis that it might be effective in other causes of chronic macular edema. We plan to conduct a pilot study of the effects of pegaptanib (up to 3 treatments of pegaptanib given as often as every 6 weeks for up to 12 weeks) in subjects with chronic post-surgical CME. If pegaptanib treatment is shown to be beneficial for this condition, additional studies could be performed to prove long-term effectiveness in patients with chronic CME or even for prophylaxis for patients known to be at high risk of developing CME following ocular surgery.
- Conditions
- Cystoid Macular Edema
- Being tested
- Pegaptanib Sodium, Control
- Keywords
- CME, Pegaptanib, Post-Surgical Ocular Inflammation
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegaptanib SodiumDrug
Also called Macugen
0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
ControlDrug
Sham injections, every 6 weeks, up to a total of 3 sham injections
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Pegaptanib Sodium |
| B | Placebo comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects improving >/= 15 letters (3 lines) of best-corrected distance visual acuity at 18 weeks after initiation of pegaptanib. Distribution of visual acuity changes at 18 weeks after initiation of pegaptanib
Measured: 18 weeks after enrollment
Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib
Measured: 18 weeks after enrollment
Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after initiation of pegaptanib using a 2-state stochastic model to account for events and recoveries from events
Measured: 18 weeks after enrollment
Secondary outcomes (3)
Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib
Measured: 18 weeks after enrollment
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib
Measured: 18 weeks after enrollment
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Difficulty enrolling eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Investigators
- Diana V. Do, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358423
- Sponsor's protocol ID
- NA_00001702
- Status last verified
- May 2008
- First submitted
- 27 Jul 2006
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Pegaptanib Sodium in Patients With Chronic, Post-Operative Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT00358423
- Acronym / sponsor ID
- NA_00001702
- Conditions
- Cystoid Macular Edema
- Keywords
- CME, Pegaptanib, Post-Surgical Ocular Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling eligible subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Study start
- Jul 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 31 Jul 2006 (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 research is being done to look at the effects of an experimental drug called pegaptanib (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that can occur after cataract surgery. Swelling in the retina can lead to blurry vision.
The only treatment available for this condition is eye drops that decrease swelling in the back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after cataract surgery.
Detailed description
While only 1% to 2% of people following cataract surgery develop visual acuity loss from chronic post-surgical cystoid macular edema (CME), this represents approximately 20,000 individuals in the U.S. each year, and many more throughout the world. No current drug or surgical treatment is very effective in the management of chronic post-surgical CME. Topical non-steroidal anti-inflammatory medications, such as ketorolac drops 4 times a day (qid) for 3 months, have been shown to reduce the extent of fluorescein leakage on angiography in patients with this condition; however, compliance can be difficult, not all cases resolve following this treatment, the drop is not approved for this indication, and it is unknown if this treatment has an effect that lasts beyond 3 to 6 months. The fluorescein angiographic findings and the effects of ketorolac drops suggest that the condition is a result of increased permeability from inflammation and might resolve with a therapy that decreases abnormal vessel permeability. Recent studies have shown that vascular endothelial growth factor (VEGF) plays a major role in vessel permeability. Pegaptanib (Macugen) is an FDA-approved drug for wet AMD. Pegaptanib is a selective VEGF antagonist that blocks the effects of VEGF; therefore,pegaptanib may decrease vessel permeability and possibly decrease CME. Pegaptanib has been shown to have some activity in reducing retinal blood vessel leakage in diabetic patients with chronic macular edema (Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-57.), further supporting the hypothesis that it might be effective in other causes of chronic macular edema. We plan to conduct a pilot study of the effects of pegaptanib (up to 3 treatments of pegaptanib given as often as every 6 weeks for up to 12 weeks) in subjects with chronic post-surgical CME. If pegaptanib treatment is shown to be beneficial for this condition, additional studies could be performed to prove long-term effectiveness in patients with chronic CME or even for prophylaxis for patients known to be at high risk of developing CME following ocular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Pegaptanib Sodium |
| B | Placebo comparator | Drug: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (ages 18 years or older)
- Best corrected visual acuity < 20/40 but no worse than 20/800 in the study eye
- Best corrected visual acuity better than or equal to 20/200 in the fellow eye
- Post-surgical CME in the study eye as documented on OCT (central subfield >/= 250 microns)
- Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed.
Key exclusion criteria (3 listed)
- History of intravitreal steroid (triamcinolone) injection into the study eye or fellow eye within 4 months prior to cataract surgery
- CME due to other etiologies such as vein occlusion and diabetes.
- Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole).
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 |
|---|---|---|
| Pegaptanib SodiumAlso: Macugen0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections | Drug | A |
| ControlSham injections, every 6 weeks, up to a total of 3 sham injections | Drug | B |
Primary outcome
Proportion of subjects improving >/= 15 letters (3 lines) of best-corrected distance visual acuity at 18 weeks after initiation of pegaptanib. Distribution of visual acuity changes at 18 weeks after initiation of pegaptanib
Time frame: 18 weeks after enrollment
Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib
Time frame: 18 weeks after enrollment
Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after initiation of pegaptanib using a 2-state stochastic model to account for events and recoveries from events
Time frame: 18 weeks after enrollment
3 secondary outcomes
Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib
Time frame: 18 weeks after enrollment
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib
Time frame: 18 weeks after enrollment
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Time frame: 6 months after enrollment
Results and safety
The study was stopped early (reason given: Difficulty enrolling eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
Related trials for Cystoid Macular Edema
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
RecruitingPhase 1/2
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
Cystoid Macular Edema
Recruiting
Effect of Video Viewing on Intravitreal Injection Experience
Age Related Macular Degeneration, Diabetic Retinopathy
Enrolling by invitationPhase 3
Intravitreal and Intracameral DEX in NPDR
Non-Proliferative Diabetic Retinopathy
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.
Diana V. Do, MD principal investigator
Johns Hopkins University
1 site 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 Pegaptanib Sodium in people with Cystoid Macular Edema, run by Johns Hopkins University 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 May 2008. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Difficulty enrolling eligible subjects). 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?
Proportion of subjects improving >/= 15 letters (3 lines) of best-corrected distance visual acuity at 18 weeks after initiation of pegaptanib. Distribution of visual acuity changes at 18 weeks after initiation of pegaptanib (time frame: 18 weeks after enrollment). The study lists 3 primary outcomes in all. 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 12 May 2008.