Age-Related MaculopathyPhase 1NCT00877032

Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

A Phase 1 study testing RN6G in people with Age-Related Maculopathy and Age-Related Maculopathies, run by Pfizer at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases
What is being tested?: RN6G
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 20 sitesUnited States
Study dates: Apr 2009to Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be of non-childbearing potential.
Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
BCVA of 20/320 or better in the worst eye.

Who cannot join

Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
Diagnosis or recent history of clinically significant cerebrovascular disease.
Uncontrolled hypertension.
Uncontrolled Type 1 or Type 2 diabetes mellitus.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

EZ Pass Rx
Bountiful, Utah, 84010
Amir Hedayati-Rad, MD
Glendale, California, 91206
United Medical Imaging
Inglewood, California, 90301
United Medical Research Institute
Inglewood, California, 90301
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
Jonathan Rowe, MD
Kalamazoo, Michigan, 49048
Ronald VanderLugt, MD
Kalamazoo, Michigan, 49048
California Pharmacy and Compounding Center
Newport Beach, California, 92660
Dedicated Phase 1
Phoenix, Arizona, 85013
Retinal Consultants of AZ
Phoenix, Arizona, 85014
Insight Diagnostic Imaging Center
Phoenix, Arizona, 85015
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Rocky Mountain Eye Care Associates, LC
Salt Lake City, Utah, 84107
Western Neurological Associates
Salt Lake City, Utah, 84124
CEDRA Clinical Research, LLC
San Antonio, Texas, 78217
Village Drive Imaging Center
San Antonio, Texas, 78217
Specialty MRI
San Antonio, Texas, 78229
Medical Center Ophthalmology Associates
San Antonio, Texas, 78233
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A Phase I, Double-masked, Placebo-controlled Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of Single Escalating Doses Of Rn6g In Patients With Dry, Age-related Macular Degeneration (Amd)

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

Conditions: Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration
Being tested: RN6G, Placebo
Keywords: Phase 1, Dry Age Related Macular Degeneration, RN6G
Medical subject headings: Macular Degeneration, Eye Diseases, Retinal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RN6GBiological
intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.
PlaceboBiological
intravenous, single dose with experimental dose.

Study groups in NCT00877032
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Biological: RN6G; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Severity of Ocular Adverse Events (AEs)
AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.
Measured: Baseline up to Day 168
Incidence and Severity of Systemic Adverse Events (AEs)
AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.
Measured: Baseline up to Day 168

Secondary outcomes (12)

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G
AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Maximum Observed Plasma Concentration (Cmax) of RN6G
Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G
Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Volume of Distribution (Vd) of RN6G
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Clearance (CL) of RN6G
CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Mean Residence Time (MRT) of RN6G
MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Plasma Terminal Half-life (t1/2) of RN6G
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)
AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.
Measured: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165
Number of Participants With Anti-Drug Anti-body
Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.
Measured: Baseline up to Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jul 2011

First posted7 Apr 2009 (estimated)
Study startApr 2009
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Age-Related MaculopathyStudies of the same condition, open and under way.
More trials run by PfizerThe 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877032
Sponsor's protocol ID: B1181001
Status last verified: Mar 2015
First submitted: 6 Apr 2009
Last updated: 31 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Age-Related Maculopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-masked, Placebo-controlled Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of Single Escalating Doses Of Rn6g In Patients With Dry, Age-related Macular Degeneration (Amd)
ClinicalTrials.gov ID: NCT00877032
Acronym / sponsor ID: B1181001
Conditions: Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration
Keywords: Phase 1, Dry Age Related Macular Degeneration, RN6G
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 7 Apr 2009 (estimated)
Results: Posted 31 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Biological: RN6G, Biological: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Be of non-childbearing potential.
Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
BCVA of 20/320 or better in the worst eye.

Key exclusion criteria (5 listed)

Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
Diagnosis or recent history of clinically significant cerebrovascular disease.
Uncontrolled hypertension.
Uncontrolled Type 1 or Type 2 diabetes mellitus.

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
RN6Gintravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.	Biological	Arm 1
Placebointravenous, single dose with experimental dose.	Biological	Arm 1

Primary outcome

Incidence and Severity of Ocular Adverse Events (AEs)
Time frame: Baseline up to Day 168
AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.
Incidence and Severity of Systemic Adverse Events (AEs)
Time frame: Baseline up to Day 168
AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.

12 secondary outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Maximum Observed Plasma Concentration (Cmax) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Volume of Distribution (Vd) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Clearance (CL) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Mean Residence Time (MRT) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Plasma Terminal Half-life (t1/2) of RN6G
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168
Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)
Time frame: Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165
Number of Participants With Anti-Drug Anti-body
Time frame: Baseline up to Day 168

Results and safety

Results posted to the registry on 31 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RN6G 0.3 mg/kg	6	6
RN6G 1 mg/kg	6	6
RN6G 3 mg/kg	6	6
RN6G 10 mg/kg	7	6
RN6G 20 mg/kg	6	6
RN6G 40 mg/kg	6	6
Placebo	20	18

Primary outcome: Incidence and Severity of Ocular Adverse Events (AEs)

Time frame: Baseline up to Day 168. Number. Unit: participants

Measure	RN6G 0.3 mg/kg n = 6	RN6G 1 mg/kg n = 6	RN6G 3 mg/kg n = 6	RN6G 10 mg/kg n = 6	RN6G 20 mg/kg n = 6	RN6G 40 mg/kg n = 6	Placebo n = 18
Ocular AEs	1	3	2	1	4	3	6
Mild ocular AEs: right eye	1	1	1	0	1	0	2
Mild ocular AEs: left eye	1	2	1	0	1	2	2
Mild ocular AEs: both eyes	0	1	1	1	2	1	3
Moderate ocular AEs: right eye	1	1	1	0	1	0	1
Moderate ocular AEs: left eye	1	0	0	0	2	0	1
Moderate ocular AEs: both eyes	0	0	0	0	0	0	0
Severe ocular AEs: right eye	0	0	0	0	0	0	0

Population analysed: Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.

Primary outcome: Incidence and Severity of Systemic Adverse Events (AEs)

Time frame: Baseline up to Day 168. Number. Unit: participants

Measure	RN6G 0.3 mg/kg n = 6	RN6G 1 mg/kg n = 6	RN6G 3 mg/kg n = 6	RN6G 10 mg/kg n = 6	RN6G 20 mg/kg n = 6	RN6G 40 mg/kg n = 6	Placebo n = 18
Systemic AEs	4	5	5	4	6	6	15
Mild systemic AEs	4	5	5	2	6	5	15
Moderate systemic AEs	1	2	2	2	3	2	7
Severe systemic AEs	0	0	0	0	0	0	0

Population analysed: Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RN6G 0.3 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
RN6G 1 mg/kg	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
RN6G 3 mg/kg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
RN6G 10 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
RN6G 20 mg/kg	0 of 6 (0%)	6 of 6 (100%)	Not reported
RN6G 40 mg/kg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Placebo	0 of 18 (0%)	15 of 18 (83.3%)	Not reported

Limitations and caveats (from the sponsor): Results for pharmacodynamic parameters \[Cmax, Tmax and AUC (0-65d) of A beta(1-X)\], are presented as absolute values at specified time points and not as change from baseline as planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RN6G in people with Age-Related Maculopathy and Age-Related Maculopathies, run by Pfizer at 20 sites 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 5 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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?

Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence and Severity of Ocular Adverse Events (AEs) (time frame: Baseline up to Day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00877032.

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 31 Mar 2015.