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NCTID/Status
Study
Last Changed

1
NCT01676766
Terminated
November 4, 2016

2
NCT01977846
Completed
October 19, 2017

3
NCT03033108
Completed
January 17, 2018

4
NCT03364153
Recruiting
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

Conditions: Stargardt Disease 1
Intervention: Zimura, Sham
September 20, 2018


6
NCT01367444
Recruiting
Phase I/II Study of SAR422459 in Patients With Stargardt's Macular Degeneration

Conditions: Stargardt's Disease
Intervention: SAR422459
July 9, 2018

7
NCT01736592
Recruiting
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration

Conditions: Stargardt's Disease
Intervention: SAR422459 Administered In Previous Study TDU13583
July 9, 2018

8
NCT03297515
Not yet recruiting
Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease

Conditions: Dry AMD; Stargardt Disease 1
Intervention: Madeos, Placebo
October 17, 2017

9
NCT02875704
Recruiting
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

Conditions: Stargardt Disease; Diabetic Retinopathy; Macular Degeneration (Age Related)
Intervention: Anterior Chamber (AC) Tap
June 9, 2018

10
NCT02402660
Recruiting
Phase 2 Tolerability and Effects of ALK-001 on Stargardt Disease

Conditions: Stargardt Disease; Stargardt Macular Degeneration; Stargardt Macular Dystrophy; Autosomal Recessive Stargardt Disease 1 (ABCA4-related)
Intervention: ALK-001, Placebo
January 11, 2018

11
NCT01345006
Completed
February 20, 2017

12
NCT02445612
Active, not recruiting
May 24, 2018



15
NCT01625559
Unknown status
Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)

Conditions: Stargardt's Macular Dystrophy
Intervention: MA09-hRPE
February 16, 2015

16
NCT00420602
Completed
DHA Supplementation in Patients With STGD3

Conditions: Dominantly Inherited Stargardt's Disease (STGD3)
Intervention: Over The Counter DHA/EPA Dietary Supplementation
May 8, 2018

17
NCT00346853
Completed
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy

Conditions: Macular Dystrophy, Corneal
Intervention: 4-Methylpyrazole, Saline
July 9, 2008

18
NCT00060749
Completed
Effect of DHA Supplements on Macular Function in Patients With Stargardt Macular Dystrophy and Stargardt-like Macular Dystrophy

Conditions: Macular Degeneration
Intervention: Docosahexaenoic Acid (DHA) Dietary Supplement
June 30, 2017

19
NCT02617966
Recruiting
Rod and Cone Mediated Function in Retinal Disease

Conditions: Retinal Degeneration; Retinitis Pigmentosa; Stargardt's Disease
August 8, 2018

20
NCT02749734
Active, not recruiting
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

Conditions: Macular Degeneration; Stargardt's Macular Dystrophy
Intervention: Subretinal Transplantation
January 29, 2018

21
NCT01278277
Active, not recruiting
Saffron Supplementation in Stargardt's Disease

Conditions: Retinal Degeneration; Genetic Disease; Single-Gene Defects; Macular Dystrophy
Intervention: Saffron Supplementation, Placebo
July 18, 2017

22
NCT01145196
Recruiting
August 28, 2018

23
NCT02230228
Completed
Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Conditions: Stargardt Disease; Age-related Macular Degeneration; Other Retinal Dystrophies
Intervention: ALK-001 (No Generic Name)
March 21, 2015

24
NCT02903576
Recruiting
Stem Cell Therapy for Outer Retinal Degenerations

Conditions: Age Related Macular Degeneration; Stargardt's Disease; Exudative Age-related Macular Degeneration
Intervention: Injection Of HESC-RPE In Suspension, Injection HESC-RPE Seeded In A Substrate
August 8, 2017

25
NCT01790958
Completed
Microcurrent Stimulation to Treat Macular Degeneration

Conditions: Retinal Diseases; Stargardt's Disease; Retinitis Pigmentosa
February 11, 2013

26
NCT03011541
Recruiting
Stem Cell Ophthalmology Treatment Study II

Conditions: Retinal Disease; Age-Related Macular Degeneration; Retinitis Pigmentosa; Stargardt Disease; Optic Neuropathy; Nonarteritic Ischemic Optic Neuropathy; Optic Atrophy; Optic Nerve Disease; Glaucoma; Leber Hereditary Optic Neuropathy; Blindness; Vision Loss Night; Vision Loss Partial; Vision, Low; Retinopathy; Maculopathy; Macular Degeneration; Retina Atrophy
Intervention: Arm 1, Arm 2, Arm 3
February 1, 2018

27
NCT02435940
Recruiting
Inherited Retinal Degenerative Disease Registry

Conditions: Eye Diseases Hereditary; Retinal Disease; Achromatopsia; Bardet-Biedl Syndrome; Bassen-Kornzweig Syndrome; Batten Disease; Best Disease; Choroidal Dystrophy; Choroideremia; Cone Dystrophy; Cone-Rod Dystrophy; Congenital Stationary Night Blindness; Enhanced S-Cone Syndrome; Fundus Albipunctatus; Goldmann-Favre Syndrome; Gyrate Atrophy; Juvenile Macular Degeneration; Kearns-Sayre Syndrome; Leber Congenital Amaurosis; Refsum Syndrome; Retinitis Pigmentosa; Retinitis Punctata Albescens; Retinoschisis; Rod-Cone Dystrophy; Rod Dystrophy; Rod Monochromacy; Stargardt Disease; Usher Syndrome
September 13, 2017

28
NCT01920867
Enrolling by invitation
Stem Cell Ophthalmology Treatment Study

Conditions: Retinal Disease; Macular Degeneration; Hereditary Retinal Dystrophy; Optic Nerve Disease; Glaucoma
Intervention: RB (Retrobulbar), ST (Subtenon), IV (Intravenous), IVIT (Intravitreal), IO (Intraocular)
August 7, 2018



Last Updated

The last updated date is the most recent date when changes to a clinical trial were submitted to ClinicalTrials.gov. There is often a delay of a few days before the updated trial is available on the clinical trials website.

Specify a From date to find the most recently changed trials. Specify both From and To dates to find trials changed during a certain period. If no dates are given, all trials will be included.

Dates should be given in a MM/DD/YYYY format, as in 1/1/2006 or 8/17/2004.

First Received

The first received date is the date when the clinical trial was first submitted to ClinicalTrials.gov. There is often a delay of a few days before the trial is available on the clinical trials website.

Clinical trial records are often updated after they have been published. The first received, last updated, start, and end dates are all displayed in the full text view of the clinical trial.

Specify a From date to find the most recent trials. Specify both From and To dates to find trials submitted during a certain period. If no dates are given, all trials will be included.

Dates should be given in a MM/DD/YYYY format, as in 1/1/2006 or 8/17/2004.

Safety Issue

If selected, restricts search results to those studies which have an outcome measure designated as a safety issue. Note that this is a poor estimate of the safety of a treatment or intervention, but it is all we have now.

Funded By

Studies are supported by one or more organizations called sponsors. Support includes contributions of facilities, expertise, and/or financial resources. All sponsors in the database have been assigned one of the following organization types:

National Institutes of Health (NIH)

Other U.S. Federal Agency - Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Department of Veterans Affairs (VA), etc.

Industry - the pharmaceutical companies

University/Organization - all others, including community-based organizations

Click the check box to the left of each organization type that you wish to include in your search. You can select more than one organization type. If you do not select any type, all types will be included.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

Click the check box to the left of each study phase that you wish to include in your search. You can select more than one study phase. If you do not select a any phase, all phases will be included.

Age Group

Studies may be designed for participants of particular ages:

Children (birth-17 yrs old)

Adults (18-65 yrs old)

Senior (66+ yrs old)

Click the check box to the left of each age group that you wish to include in your search. You can select more than one age group. If you do not select a any group, all groups will be included.

Gender

Searches can be restricted to studies which accept female or male participants.
Location Terms

If you are interested in a specific city (such as Los Angeles) or facility name (such as the Mayo Clinic), enter it as a location term. Not all studies include this level of detail, but if they do, this will find them.

Countries and States

Trials are often conducted at many locations around the world. Select up to three locations to find trials conducted in specific countries. Some countries (currently limited to the United States, Canada, and Australia), locations can be narrowed further by selecting a state.

Study IDs

Each trial is assigned one or more identification numbers by the institute, agency, or organization sponsoring the trial. In addition, clinical trials assigns a unique NCT identifier of the form NCTxxxxxxxx where each x is a numeric digit. Use this box to search for a trial by NCT identifier or any other study identification numbers.

Examples:

NCT00001789
97-h-0197
ia0006
actg 076

Sponsor (Lead)

Use this box to specify the name of an institute, organization, or company that is conducting a trial.

It is common for several organizations to collaborate by providing funding, facilities, experimental treatments, etc. Which organization is considered the sponsor is decided by the data provider.

A search in this area will check only the sponsor field. To also look for collaborators, use the Sponsor/Collaborators search box.

When the Exact Match checkbox is checked, the sponsor name in the study must exactly match the sponsor name in the search. For example, if unchecked, a search for Merck in the lead sponsor field will find Merck, Merck KGaA, Dupont Merck, and Merck Sharp & Dohme. When checked, only Merck, with no other words in the name, will be found.

Examples:

National Cancer Institute
Mayo Clinic
Bristol-Myers Squibb
Sponsor/Collaborators

Use this box to specify institutes, organizations, or companies that are conducting or otherwise supporting a trial.

It is common for several organizations to collaborate by providing funding, facilities, experimental treatments, etc. Which organization is considered the sponsor is decided by the data provider.

Searching this area will look in both the sponsor field and in the collaborators field. To only look in the sponsor field, use the Sponsor (Lead) search box.

When the Exact Match checkbox is checked, the name in the study must exactly match the name in the search. For example, if unchecked, a search for Merck will find Merck, Merck KGaA, Dupont Merck, and Merck Sharp & Dohme. When checked, only Merck, with no other words in the name, will be found.

Examples:

National Cancer Institute
Mayo Clinic
Bristol-Myers Squibb

Outcome Measures

Outcome measures are used to evaluate trial results. For example, an obesity treatment might be evaluated by a measure of weight loss after 6 months. Measures can also be used to quantify side effects, such as number of myocardial infarctions, number of patients with heart arrhythmia, number of suicides, etc.

Use this box to specify an outcome measure used to evaluate trial results.

Examples:

weight loss
heart failure
suicide

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Use this box to specify drugs, devices, procedures, or vaccines used in a trial.

Examples:

clofibrate
cyclosporine
vitamin e

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Use this box to specify the conditions being studied.

Examples:

lupus
heart attack
leukemia
risk factors for breast cancer

Study Type

There are three types of studies available in ClinicalTrials.gov:

Interventional:

Studies where individuals are assigned to receive specific interventions. Participants may receive diagnostic, therapeutic or other types of interventions. Assignment of the intervention may or may not be random. Individuals are tracked and biomedical and/or health outcomes are assessed.

Observational:

Studies without an intervention. Studies where biomedical and/or health outcomes are assessed in a pre-defined group of individuals. Participants may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the participants of the study.

Expanded Access:

Records describing the procedure for obtaining an experimental drug or device for patients who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.

Study Results

Searches can be restricted to studies with or without results.

The inclusion of study results is a relatively new feature of ClinicalTrials.gov. Collection of results began in September of 2008. Almost all older studies and some newer studies do not include results. As time goes on, there will be more results available.

Recruitment Status

Also known as Enrollment Status.

Not all clinical trials in this database are accepting new participants. If you are looking for studies that are currently recruiting participants, will be recruiting in the future, or are about drugs that are available for expanded access, select Open Studies in the recruitment menu.

If you are interested in all trials, whether they are recruiting new participants or not, leave the menu with All Studies selected.

Trials may not be recruiting because they are full, completed, or halted for various reasons. In addition, some trials have very restrictive eligibility requirements and must seek participants by invitation only. To see these studies, Select Closed Studies in the recruitment menu.

Full list of all possible recruitment status values:

Open recruitment status values:

Recruiting,
Not yet recruiting, or
Available for expanded access.

Closed recruitment status values:

Active, not recruiting,
Completed,
Terminated,
Suspended,
Withdrawn,
Enrolling by invitation,
Temporarily not available for expanded access,
No longer available for expanded access,
Approved for marketing, or
Unknown.

Values are color coded (as shown) in the search results.

Search Terms

Use this box to specify general search terms found anywhere in the trial record.

Multiple terms can be separated by an AND (all uppercase).

Examples:

type ii diabetes
veterans affairs medical center
heart attacks in older adults
nhlbi AND heart disease
Cisplatin AND safety study


Help for Searching clinical trials

Help Topics:


Basic Search:

On the Basic Search page, enter a word or word(s) that you want to use to find studies. These may include diseases, interventions, and/or locations.

Medical terms are often several words long, such as Percutaneous Coronary Intervention. To only find studies where the words are together as a phrase, put the term in quotes (e.g., "Percutaneous Coronary Intervention"). If you search for a multi-word term without quotes, studies with all words together as a phrase will appear higher in the results list than studies where the words are separated and spread throughout the document. For example, a search for Heart Attack will list a study about,
Use of a Pacemaker Following a Heart Attack.
higher than the study,
Heart Defects and Transient Ischemic Attacks

A search for "Heart Attack" would not find the second study. Synonyms are known for some terms and are used where possible. For example, a search for Heart Attack will also find occurrences of Myocardial Infarction.


Advanced Search:

Many searches are a single term and can be performed with a few words in the search box. But, sometimes you need more control. Click on the Advanced Search tab (if starting a new search) or Refine Search tab (if modifying an existing search) to show additional search fields.

The additional search fields can be used to limit your search results. Note that it is not necessary to fill in all the fields, only those that are needed for your search. If you are finding too few studies, consider clearing a field and searching again.

Search Terms:
Performs a general search in all sections of the study record, including title, description, conditions, interventions, locations, etc. Terms in this field are searched the same as Basic Search.

Recruitment:
Limits search results to studies that are open or closed. New volunteers may be able to participate in open studies, but not closed studies.

Open recruitment status values:
Recruiting,
Not yet recruiting, or
Available for expanded access.

Closed recruitment status values:
Active, not recruiting,
Completed,
Terminated,
Suspended,
Withdrawn,
Enrolling by invitation,
Temporarily not available for expanded access,
No longer available for expanded access,
Approved for marketing, or
Unknown.

Values are color coded (as shown) in the search results.

Study Results:
Limits search results based on whether the study has results or not:
All Studies,
Studies With Results, or
Studies Without Results
The inclusion of Study Results is a new feature of ClinicalTrials.gov. Only a few studies have results available.

Study Type:
Limits search results to any of the following study types:
Interventional,
Observational, or
Expanded Access

Conditions:
Performs a search on fields describing the diseases or conditions being studied.

Interventions:
Performs a search on fields listing the drugs or interventions being studied.

Outcomes Measures:
Performs a search on fields listing the outcome measures used to quantify study results.

Sponsor/Collaborators:
Performs a search on fields listing the sponsor and collaborators of a study.

When the Exact Match checkbox is checked, the sponsor/collaborator name in the study must exactly match the name in the search. For example, if unchecked, a search for Merck in the sponsor/collaborator field will find Merck, Merck KGaA, Dupont Merck, and Merck Sharp & Dohme. When checked, only Merck, with no other words in the name, will be found.

Sponsor (Lead):
Performs a search on the sponsor field of a study.

It is common for several organizations to collaborate by providing funding, facilities, experimental treatments, etc. Which organization is considered the "sponsor" is decided by the data provider.

When the Exact Match checkbox is checked, the lead sponsor name in the study must exactly match the lead sponsor name in the search. For example, if unchecked, a search for Merck in the lead sponsor field will find Merck, Merck KGaA, Dupont Merck, and Merck Sharp & Dohme. When checked, only Merck, with no other words in the name, will be found.

Study IDs:
Performs a search on fields listing ID numbers.

Country/State:
Trials are often conducted at many locations around the world. Select up to three locations to find trials conducted in specific countries. Some countries (currently limited to the United States, Canada, and Australia), locations can be narrowed further by selecting a state (e.g., United States, Alabama).

Location Terms:
Finds studies in specific locations such as a city (Los Angeles) or facility (Mayo Clinic). Not all studies include this level of detail, but if they do, this will find them.

Gender:
Limits search results to those studies that accept female or male participants.

Age Group:
Limits search results to those studies that include at least one of the specified age ranges. More than one age group can be selected.

Phase:
Limits search results to studies that are labeled with at least one of the specified phases. More than one Phase can be selected.

Funded By:
Limits search results to studies that have at least one sponsor of the specified types. More than one sponsor type can be selected.

Safety Issue:
Limits search results to studies that have at least one outcome measure designated as a safety issue.

First Received:
Limits search results to studies that were received by clinical trials within a specified date range. The "From" or "To" field can be left blank.

Last Updated:
Limits search results to studies that were modified within a specified date range. The "From" or "To" field can be left blank.


Refine Search:

Searches display a list of studies found (List Results tab). If you are not content with the search results, click on the Refine Search tab at the top of the list to modify your search.

Add terms to empty fields to search within your current result. You can also add terms to fields that contain terms. For best results, use an AND (all upper case) as a separator between terms in the same field.

For example:
heart attack
heart attack AND aspirin
heart attack AND aspirin AND older adults
heart attack AND aspirin AND older adults AND California

When you are done making changes, click Search to display the new results.


Search Expressions:

Use AND (all upper case) to find study records that contain all terms connected by AND.
For example:
prostate cancer AND radiation
heart disease AND stroke AND California

Use OR (all upper case) to find study records that contain either term connected by OR.
For example:
Aspirin OR ibuprofen
heart disease OR heart attack

Use NOT (all upper case) to find study records that do not contain the term following NOT.
For example:
Immunodeficiency NOT AIDS

Likewise, AND, OR, NOT, and parentheses can be used to create more complicated search expressions.
For example:
prostate cancer AND NOT ( radiation OR homeopathic remedies )
( heart disease OR heart attack ) AND ( stroke OR clot )

Note that the use of AND and OR as logical operators can be confusing.
An appropriate search for a list such as,
Ear, Nose, and Throat Conditions
is the expression
( Ear OR Nose OR Throat ) AND Conditions
Fortunately, search will do a pretty good job of finding the right studies either way.

To search for AND as a word, instead of using it as an operator, put it in quotes.
Likewise, you can quote OR, NOT, and parentheses.



© 2018 ICH GCP