Cystoid Macular EdemaPhase 1/2NCT00346983
Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics
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 conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 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) with diabetes mellitus
- Best corrected visual acuity worse than 20/40 but no worse than 20/800 in the study eye
- Best corrected visual acuity better than or equal to 20/800 in the fellow eye
- DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery
- No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery
- 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.
Who cannot join
- History of intravitreal steroid (triamcinolone) injection into the study eye within 4 months prior to cataract surgery
- Macular edema due to non-diabetic etiologies such as vein occlusion
- Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole)
- Media opacity will not be an exclusion criterion provided that the investigator can assess the presence or absence of DME on OCT
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 to Prevent Worsening of Cystoid Macular Edema Following Cataract Surgery in Diabetics
This research is being conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having cataract surgery.
Read the detailed description
Macular edema occurs as a complication of cataract surgery in approximately 2% of all surgeries. In this condition, cystic, fluid-filled spaces develop in the outer plexiform layer of the retina resulting in a loss of vision. This condition is termed "Cystoid Macular Edema (CME)." In non-diabetics, the majority of such cases resolve spontaneously.
Diabetic macular edema (DME) is an important cause of visual disability among patients with diabetes. It is widely recognized that cataract surgery often triggers severe CME in patients with pre-existing DME. This exacerbation begins immediately following cataract surgery; and unlike in non-diabetics the edema is likely to be protracted and poorly responsive both to traditional treatments for CME (topical NSAIDS) and DME (laser photocoagulation). Fluorescein angiography, a photographic test that evaluates the blood circulation in the back of the eye, has demonstrated that both CME and DME are associated with increased permeability of retinal blood vessels.
The high rates and severity of post-cataract surgery CME in diabetic patients with DME render this population ideal for the study of potential agents to reduce the rate and severity of this condition (i.e., post-cataract surgery CME). 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 might decrease vessel permeability and possibly decrease the incidence and severity of CME. We plan to conduct a controlled pilot study to investigate the effects of pegaptanib (up to 3 treatments of pegaptanib given prior to cataract surgery and as often as every 6 weeks for up to 12 weeks after cataract surgery) in diabetic patients with pre-existing DME who are undergoing cataract surgery and who are, therefore, at very high risk for development of CME. Should the pilot study indicate a potential benefit of pegaptanib in this setting, a larger, fully powered clinical trial will be proposed. An effective treatment or preventive measure for post-cataract surgery macular edema in patients with diabetic retinopathy would offer benefit to a large patient population nationally that is at high risk of vision loss.
- Conditions
- Cystoid Macular Edema
- Being tested
- Pegaptanib sodium, Control
- 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
0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections
ControlDrug
Sham injection, 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 avoiding 15 letters (3 lines) of best-corrected distance visual acuity loss at 18 weeks after cataract surgery. Distribution of visual acuity changes at 18 weeks after cataract surgery
Measured: 1 to 18 weeks post-cataract surgery
Distribution of absolute levels of distance visual acuity at 18 weeks after cataract surgery
Measured: 1 to 18 weeks post-cataract surgery
Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after cataract surgery using a 2-state stochastic model to account for events and recoveries from events
Measured: 1 to 18 weeks post-cataract surgery
Secondary outcomes (4)
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after cataract surgery
Measured: pre-cataract surgery to 18 weeks post-cataract surgery
Analysis of decrease in retinal thickness by OCT at 18 weeks after cataract surgery
Measured: pre-cataract surgery to 18 weeks post-cataract surgery
Analysis of level of diabetic retinopathy using recognized photographic grading system at 18 weeks after cataract surgery
Measured: pre-cataract surgery to 18 weeks post-cataract surgery
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Measured: pre-cataract surgery to 6 months post-cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2007
- Study completionMay 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Investigators
- Oliver D. Schein, MD, MPH, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346983
- Sponsor's protocol ID
- NA_00001385
- Status last verified
- May 2008
- First submitted
- 29 Jun 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 to Prevent Worsening of Cystoid Macular Edema Following Cataract Surgery in Diabetics
- ClinicalTrials.gov ID
- NCT00346983
- Acronym / sponsor ID
- NA_00001385
- Conditions
- Cystoid Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling eligible subjects
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Study start
- Jun 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 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 conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having cataract surgery.
Detailed description
Macular edema occurs as a complication of cataract surgery in approximately 2% of all surgeries. In this condition, cystic, fluid-filled spaces develop in the outer plexiform layer of the retina resulting in a loss of vision. This condition is termed "Cystoid Macular Edema (CME)." In non-diabetics, the majority of such cases resolve spontaneously.
Diabetic macular edema (DME) is an important cause of visual disability among patients with diabetes. It is widely recognized that cataract surgery often triggers severe CME in patients with pre-existing DME. This exacerbation begins immediately following cataract surgery; and unlike in non-diabetics the edema is likely to be protracted and poorly responsive both to traditional treatments for CME (topical NSAIDS) and DME (laser photocoagulation). Fluorescein angiography, a photographic test that evaluates the blood circulation in the back of the eye, has demonstrated that both CME and DME are associated with increased permeability of retinal blood vessels.
The high rates and severity of post-cataract surgery CME in diabetic patients with DME render this population ideal for the study of potential agents to reduce the rate and severity of this condition (i.e., post-cataract surgery CME). 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 might decrease vessel permeability and possibly decrease the incidence and severity of CME. We plan to conduct a controlled pilot study to investigate the effects of pegaptanib (up to 3 treatments of pegaptanib given prior to cataract surgery and as often as every 6 weeks for up to 12 weeks after cataract surgery) in diabetic patients with pre-existing DME who are undergoing cataract surgery and who are, therefore, at very high risk for development of CME. Should the pilot study indicate a potential benefit of pegaptanib in this setting, a larger, fully powered clinical trial will be proposed. An effective treatment or preventive measure for post-cataract surgery macular edema in patients with diabetic retinopathy would offer benefit to a large patient population nationally that is at high risk of vision loss.
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) with diabetes mellitus
- Best corrected visual acuity worse than 20/40 but no worse than 20/800 in the study eye
- Best corrected visual acuity better than or equal to 20/800 in the fellow eye
- DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery
- No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery
Key exclusion criteria (4 listed)
- History of intravitreal steroid (triamcinolone) injection into the study eye within 4 months prior to cataract surgery
- Macular edema due to non-diabetic etiologies such as vein occlusion
- Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole)
- Media opacity will not be an exclusion criterion provided that the investigator can assess the presence or absence of DME on OCT
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: Macugen0.3mg/0.1ml intravitreal injection, every 6 weeks, up to a total of 3 injections | Drug | A |
| ControlSham injection, every 6 weeks, up to a total of 3 sham injections | Drug | B |
Primary outcome
Proportion of subjects avoiding 15 letters (3 lines) of best-corrected distance visual acuity loss at 18 weeks after cataract surgery. Distribution of visual acuity changes at 18 weeks after cataract surgery
Time frame: 1 to 18 weeks post-cataract surgery
Distribution of absolute levels of distance visual acuity at 18 weeks after cataract surgery
Time frame: 1 to 18 weeks post-cataract surgery
Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after cataract surgery using a 2-state stochastic model to account for events and recoveries from events
Time frame: 1 to 18 weeks post-cataract surgery
4 secondary outcomes
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after cataract surgery
Time frame: pre-cataract surgery to 18 weeks post-cataract surgery
Analysis of decrease in retinal thickness by OCT at 18 weeks after cataract surgery
Time frame: pre-cataract surgery to 18 weeks post-cataract surgery
Analysis of level of diabetic retinopathy using recognized photographic grading system at 18 weeks after cataract surgery
Time frame: pre-cataract surgery to 18 weeks post-cataract surgery
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Time frame: pre-cataract surgery to 6 months post-cataract surgery
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.
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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.
Oliver D. Schein, MD, MPH, MBA 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 4 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 avoiding 15 letters (3 lines) of best-corrected distance visual acuity loss at 18 weeks after cataract surgery. Distribution of visual acuity changes at 18 weeks after cataract surgery (time frame: 1 to 18 weeks post-cataract surgery). 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.